ALENDRONATE SODIUM  - alendronate sodium tablet 
Aurobindo Pharma Limited

----------

Alendronate Sodium Tablets, USP

DESCRIPTION






4 12 7 2 2
Chemical Structure



CLINICAL PHARMACOLOGY

Mechanism of Action


3 3

Pharmacokinetics

Absorption








Distribution


Metabolism


Excretion


14

Special Populations

Pediatric


Gender


Geriatric


DOSAGE AND ADMINISTRATION

Race


Renal Insufficiency




Alendronate sodium is not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience with alendronate in renal failure.

Hepatic Insufficiency


Drug Interactions


PRECAUTIONS, Drug Interactions

2



Pharmacodynamics


Osteoporosis in postmenopausal women








Osteoporosis in men

Treatment of men with osteoporosis with alendronate sodium 10 mg/day for two years reduced urinary excretion of cross-linked N-telopeptides of type I collagen by approximately 60% and bone-specific alkaline phosphatase by approximately 40%. Similar reductions were observed in a one-year study in men with osteoporosis receiving once weekly alendronate sodium 70 mg.

Glucocorticoid-induced Osteoporosis




Paget’s disease of bone






Clinical Studies

Treatment of osteoporosis

Postmenopausal women

Effect on bone mineral density


Increase in BMD Alendronate Sodium 10 mg/day at Three Years



Time Course of Effect of Alendronate Sodium 10 mg/day Versus Placebo: Lumbar Spine BMD Percent Change From Baseline




Effect on fracture incidence







Fracture Intervention Trial





Effect of Alendronate Sodium on Fracture Incidence in the Three-Year Study of FIT (patients with vertebral fracture at baseline)
                                                                            Percent of Patients

 
Alendronate Sodium
(n=1022)
 Placebo
(n=1005)
  Absolute
 Reduction
 in Fracture
  Incidence
  Relative
Reduction
in Fracture
   Risk %
Number evaluable for vertebral fractures: alendronate sodium, n=984; placebo, n=966
*p<0.05, **p<0.01, ***p<0.001, p=0.007
Patients with:

Vertebral fractures (diagnosed by X-ray)

    ≥ 1 new vertebral fracture

    ≥ 2 new vertebral fractures

Clinical (symptomatic) fractures

    Any clinical (symptomatic) fracture

    ≥ 1 clinical (symptomatic) vertebral
      fracture

Hip fracture

Wrist (forearm) fracture


 

7.9

0.5

 

13.8

2.3

                        
1.1
                        
2.2


 

15

4.9

 

18.1

5

        
2.2
        
4.1


 

7.1

4.4

 

4.3

2.7

            
1.1
            
1.9


 

47***

90***

 

26

54**

            
51
       
48*





Cumulative Incidence of Hip Fractures in the Three-Year Study of FIT

Fracture Intervention Trial




Effect of Alendronate Sodium on Fracture Incidence in Osteoporotic Patients in the Four-Year Study of FIT (patients without vertebral fracture at baseline)
                                                                            Percent of Patients

 
Alendronate Sodium
(n=1545)
Placebo
(n=1521)
Absolute
 Reduction
 in Fracture
Incidence
Relative
Reduction
in Fracture
Risk %
Baseline femoral neck BMD at least 2 SD below the mean for young adult women
†† Number evaluable for vertebral fractures: alendronate sodium, n=1426; placebo, n=1428
††† Not significant. This study was not powered to detect differences at these sites.
*p=0.035, **p=0.01, ***p<0.001
Patients with:

Vertebral fractures (diagnosed by X-ray) ††

    ≥ 1 new vertebral fracture

    ≥ 2 new vertebral fractures

Clinical (symptomatic) fractures

    Any clinical (symptomatic) fracture

    ≥ 1 clinical (symptomatic) vertebral
      fracture

Hip fracture

Wrist (forearm) fracture


 

2.5

0.1

 

12.9

1

              
1
              
3.9


 

4.8

0.6

 

16.2

1.6

      
1.4
     
3.8


 

2.3

0.5

 

3.3

0.6

      
0.4 
    
-0.1


 

48***

78*

 

22**

 41 (NS) †††

 
 29 (NS) †††
    
(NS) †††

Fracture results across studies







Bone histology

Men








Prevention of osteoporosis in postmenopausal women



Osteoporosis Prevention Studies in Postmenopausal Women

Bone histology


Concomitant use with estrogen/hormone replacement therapy (HRT)








Glucocorticoid-induced osteoporosis



Studies in Glucocorticoid – Treated Patients







Paget’s disease of bone



Studies in Paget’s Disease of Bone



Clinical Studies, Treatment of osteoporosis in postmenopausal women, Bone histology

ANIMAL PHARMACOLOGY


INDICATIONS AND USAGE





CONTRAINDICATIONS

 

WARNINGS






DOSAGE AND ADMINISTRATION



PRECAUTIONS

General




CONTRAINDICATIONS



Musculoskeletal Pain


ADVERSE REACTIONS

Dental




Renal insufficiency


DOSAGE AND ADMINISTRATION

Glucocorticoid-induced osteoporosis


INDICATIONS AND USAGE







Information for Patients

General




Dosing Instructions


CLINICAL PHARMACOLOGY, Pharmacokinetics, Absorption

and

Drug Interactions


CLINICAL PHARMACOLOGY, Pharmacokinetics, Drug Interactions

Estrogen/hormone replacement therapy (HRT)


CLINICAL PHARMACOLOGY, Clinical Studies, Concomitant use with estrogen/hormone replacement therapy (HRT) ADVERSE REACTIONS, Clinical Studies, Concomitant use with estrogen/hormone replacement therapy

Calcium Supplements/Antacids


Aspirin


Nonsteroidal Anti-inflammatory Drugs (NSAIDs)


Carcinogenesis, Mutagenesis, Impairment Of Fertility


2

2

in vitro in vitro in vitro in vivo in vitro

2

Pregnancy




2 2

2 2



Nursing Mothers

It is not known whether alendronate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when alendronate sodium is administered to nursing women.

Pediatric Use






ADVERSE REACTIONS, Clinical Studies, Osteogenesis Imperfecta

Geriatric Use


CLINICAL PHARMACOLOGY, Clinical Studies

ADVERSE REACTIONS

Clinical Studies




Treatment of osteoporosis

Postmenopausal women



Osteoporosis Treatment Studies in Postmenopausal Women Adverse Experiences Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in ≥1% of Patients
United States/Multinational Studies     Fracture Intervention Trial

 
Alendronate Sodium*
%
(n=196)
Placebo
%
(n=397)
 Alendronate Sodium**
 %
 (n=3236)
 Placebo
%
(n=3223)
*10 mg/day for three years
**5 mg/day for 2 years and 10 mg/day for either 1 or 2 additional years

Gastrointestinal

    abdominal pain

    nausea

    dyspepsia

    constipation

    diarrhea

    flatulence

    acid regurgitation

    esophageal ulcer

    vomiting

    dysphagia

    abdominal distention

    gastritis

Musculoskeletal

    musculoskeletal (bone,
       muscle or joint) pain

    muscle cramp

Nervous System/Psychiatric

    headache

    dizziness

Special Senses

    taste perversion

          
        
                 6.6
                  
                 3.6
                  
                 3.6
                  
                 3.1
                  
                 3.1
                  
                 2.6
                  
                 2
                  
                 1.5
                  
                 1
                  
                 1
                 
                 1
                   
                 0.5
                  


                 4.1
                 
 
                 0
                  


                 2.6
                   
                 0
                  
             
 
               0.5

  
 
    4.8
    
    4
    
    3.5
    
    1.8
    
    1.8
    
    0.5
    
    4.3
    
    0
    
    1.5
    
    0
    
    0.8
   
    1.3
    


    2.5
    

    1
   


    1.5
    
    1
   


    1


          
                 1.5
                  
                 1.1
                  
                 1.1
                  
                 0
                  
                 0.6
                  
                 0.2
                  
                 1.1
                  
                 0.1
                  
                 0.2
                  
                 0.1
                 
                 0
                   
                 0.6
                  


                 0.4
       
           
                 0.2
                  


                 0.2
                  
                 0
                  


                 0.1

  
 
     1.5
    
    1.5
    
    1.2
    
    0.2
    
    0.3
    
    0.3
    
    0.9
    
    0.1
    
    0.3
    
    0.1
    
    0
   
    0.7
    


    0.3
    

    0.1
   
 

    0.2
    
    0.1
   
 

    0
 








Osteoporosis Treatment Studies in Postmenopausal Women Adverse Experiences Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in ≥1% of Patients
Once Weekly
Alendronate Sodium
70 mg
%
(n=519)
Alendronate Sodium
10 mg/day
 %
(n=370)

Gastrointestinal

    abdominal pain

    dyspepsia

    acid regurgitation

    nausea  

    abdominal distention

    constipation

    flatulence

    gastritis

    gastric ulcer

            

              3.7
            
              2.7
           
              1.9
            
              1.9
             
              1
           
              0.8
            
              0.4
           
              0.2
             
              0

           
    
              3
             
              2.2
             
              2.4
             
              2.4
             
              1.4
             
              1.6
             
              1.6
             
              1.1
             
              1.1

Musculoskeletal

    musculoskeletal (bone, muscle,
         joint) pain

    muscle cramp

           
 
              2.9
            

              0.2

          

              3.2
             
          
              1.1

Men



Osteoporosis Studies in Men Adverse Experiences Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in ≥2% of Patients
           Two-year Study             One-year Study

 
Alendronate Sodium
10 mg/day
%
(n=146)
Placebo
%
 (n=95)
Once Weekly
Alendronate Sodium
70 mg
%
(n=109)
Placebo
%
(n=58)

Gastrointestinal

    acid regurgitation

    flatulence
 
    gastroesophageal
      reflux disease
 
    dyspepsia
 
    diarrhea
 
    abdominal pain 
 
    nausea

 

              4.1

              4.1

              0.7

 
              3.4

              1.4

              2.1

              2.1

 

    3.2

    1.1

    3.2

 
     0

    1.1

    1.1

    0

 

               0

               0

              2.8

 
              2.8

              2.8

              0.9

               0

 

      0

      0

      0

 
     1.7

      0

     3.4

      0

Prevention of osteoporosis in postmenopausal women







Osteoporosis Prevention Studies in Postmenopausal Women Adverse Experiences Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in ≥1% of Patients

 
      Two/Three-Year Studies
                        One-Year Study
Alendronate Sodium
        5 mg/day
              %
          (n=642)
Placebo
    %
 (n=648)
Alendronate Sodium
       5 mg/day
            %
        (n=361)
      Once Weekly
Alendronate Sodium
           35 mg
              %
          (n=362)

Gastrointestinal

    dyspepsia

    abdominal pain

    acid regurgitation

    nausea

    diarrhea

    constipation

    abdominal distention

Musculoskeletal

    musculoskeletal (bone,
        muscle or joint)
        pain

 

            1.9

            1.7

            1.4

            1.4

            1.1

            0.9

            0.2

 

            0.8

 

    1.4

    3.4

    2.5

    1.4

    1.7

    0.5

    0.3

 

    0.9

 

            2.2

            4.2

            4.2

            2.5

            1.1

            1.7

            1.4

 

            1.9

        

            1.7
            
            2.2

            4.7

            1.4

            0.6

            0.3

            1.1
 

            
            2.2

Concomitant use with estrogen/hormone replacement therapy


Treatment of glucocorticoid-induced osteoporosis



One-Year Studies in Glucocorticoid-Treated Patients Adverse Experiences Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in ≥1% of Patients

 
Alendronate Sodium
        10 mg/day
              %
          (n=157)
Alendronate Sodium
        5 mg/day
              %
          (n=161)
Placebo
    %
 (n=159)

Gastrointestinal

    abdominal pain

    acid regurgitation

    constipation

    melena

    nausea

    diarrhea

Nervous System/Psychiatric

    headache

 

            3.2

            2.5

            1.3

            1.3

            0.6

            0

 

            0.6

 

            1.9

            1.9

            0.6

            0

            1.2

            0

 

            0

 

    0

    1.3

    0

    0   

    0.6

    1.3

 

    1.3

Paget’s disease of bone




Osteogenesis Imperfecta






ADVERSE REACTIONS, Post-Marketing Experience, Body as a Whole

Laboratory Test Findings


Post-Marketing Experience




Body as a Whole:


Gastrointestinal:
WARNINGS, PRECAUTIONS, Information for Patients DOSAGE AND ADMINISTRATION

PRECAUTIONS, Dental

Musculoskeletal:
PRECAUTIONS, Musculoskeletal Pain

Nervous system:


Skin:


Special Senses: 

OVERDOSAGE


2 2 2



DOSAGE AND ADMINISTRATION


at least PRECAUTIONS, Information for Patients PRECAUTIONS, Drug Interactions

and WARNINGS PRECAUTIONS, Information for Patients

PRECAUTIONS, General



Treatment of osteoporosis in postmenopausal women (see INDICATIONS AND USAGE)



                              or

Treatment to increase bone mass in men with osteoporosis



                              or



Prevention of osteoporosis in postmenopausal women (see INDICATIONS AND USAGE)


                              or




Treatment of glucocorticoid-induced osteoporosis in men and women



Paget’s disease of bone in men and women



Retreatment of Paget’s disease

HOW SUPPLIED


Alendronate Sodium Tablets USP, 10 mg 






Alendronate Sodium Tablets USP, 35 mg






Alendronate Sodium Tablets USP, 70 mg





Store at




Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited


Patient Information

Once Weekly Alendronate Sodium Tablets, USP
Rx only

 
Read this information before you start taking alendronate sodium tablets. Also, read the leaflet each time you refill your prescription, just in case anything has changed. This leaflet does not take the place of discussions with your doctor. You and your doctor should discuss alendronate sodium tablets when you start taking your medicine and at regular checkups.

What is the most important information I should know about once weekly alendronate sodium tablets?
 


What are alendronate sodium tablets?

Alendronate sodium tablets are a prescription medicine for:
 


Improvement in bone density may be observed as early as 3 months after you start taking alendronate sodium tablets even though you won’t see or feel a difference.  For alendronate sodium tablets to continue to work, you need to keep taking them.

Alendronate sodium tablet is not a hormone.

There is more information about osteoporosis at the end of this leaflet.

Who should not take alendronate sodium tablets?

Do not take alendronate sodium tablets if you:
 


What should I tell my doctor before using alendronate sodium tablets?

Tell your doctor about all of your medical conditions, including if you:
 


Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.

How should I take once weekly alendronate sodium tablets?
 


Do not take alendronate sodium tablets with:

Mineral water
Coffee or tea
Juice

Alendronate sodium tablets work only if taken on an empty stomach.

Do not chew or suck on a tablet of alendronate sodium.


After taking your alendronate sodium tablets, wait at least 30 minutes:
 



Do not lie down until after your first food of the day.
 



What should I do if I miss a dose of alendronate sodium tablets or if I take too many?
 



What should I avoid while taking alendronate sodium tablets?
 



What are the possible side effects of alendronate sodium tablets?

Alendronate sodium tablets may cause problems in your esophagus (the tube that connects the mouth and stomach).  (See “What is the most important information I should know about once weekly alendronate sodium tablets?”.) These problems include irritation, inflammation, or ulcers of the esophagus, which may sometimes bleed. This may occur especially if you do not drink a full glass of water with alendronate sodium tablets or if you lie down in less than 30 minutes or before your first food of the day.
 



Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the side effects with alendronate sodium tablets. Ask your doctor or pharmacist for more information.

How do I store alendronate sodium tablets?
 



General information about using alendronate sodium tablets safely and effectively

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use alendronate sodium tablets for a condition for which it was not prescribed. Do not give alendronate sodium tablets to other people, even if they have the same symptoms you have. They may harm them.

Alendronate sodium tablets are not indicated for use in children.

This leaflet is a summary of information about alendronate sodium tablets. If you have any questions or concerns about alendronate sodium tablets or osteoporosis, talk to your doctor, pharmacist, or other health care provider. You can ask your doctor or pharmacist for information about alendronate sodium tablets written for health care providers. For more information, call 1-866-850-2876 (toll-free).
 
What are the ingredients in alendronate sodium tablets?

Alendronate sodium tablets contain alendronate sodium as the active ingredient and the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycolate, povidone, isopropyl alcohol, and magnesium stearate.

What should I know about osteoporosis?

Normally your bones are being rebuilt all the time. First, old bone is removed (resorbed). Then a similar amount of new bone is formed. This balanced process keeps your skeleton healthy and strong.

Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause, and may also occur in men. In osteoporosis, bone is removed faster than it is formed, so overall bone mass is lost and bones become weaker. Therefore, keeping bone mass is important to keep your bones healthy. In both men and women, osteoporosis may also be caused by certain medicines called corticosteroids.

At first, osteoporosis usually has no symptoms, but it can cause fractures (broken bones). Fractures usually cause pain. Fractures of the bones of the spine may not be painful, but over time they can make you shorter. Eventually, your spine can curve and your body can become bent over. Fractures may happen during normal, everyday activity, such as lifting, or from minor injury that would normally not cause bones to break. Fractures most often occur at the hip, spine, or wrist. This can lead to pain, severe disability, or loss of ability to move around (mobility).

Who is at risk for osteoporosis?
 
Many things put people at risk of osteoporosis. The following people have a higher chance of getting osteoporosis:
 
Women who:

Men who: 


 
People who:



What can I do to help prevent or treat osteoporosis?

 
In addition to alendronate sodium tablets, your doctor may suggest one or more of the following lifestyle changes:
 

 


Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
 
Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 072, India
 
Revised: 12/2008
 

Patient Information

Once Daily Alendronate Sodium Tablets, USP
Rx only
 
Read this information before you start taking alendronate sodium tablets. Also, read the leaflet each time you refill your prescription, just in case anything has changed. This leaflet does not take the place of discussions with your doctor. You and your doctor should discuss alendronate sodium tablets when you start taking your medicine and at regular checkups.

What is the most important information I should know about alendronate sodium tablets?

You must take alendronate sodium tablets exactly as directed to help make sure they work and to help lower the chance of problems in your esophagus (the tube that connects your mouth and stomach). (See “How should I take alendronate sodium tablets?”).

If you have chest pain, new or worsening heartburn, or have trouble or pain when you swallow, stop taking alendronate sodium tablets and call your doctor. (See “What are the possible side effects of alendronate sodium tablets?”).

What are alendronate sodium tablets?
 
Alendronate sodium tablets are a prescription medicine for: 



Improvement in bone density may be observed as early as 3 months after you start taking alendronate sodium tablets even though you won’t see or feel a difference. For alendronate sodium tablets to continue to work, you need to keep taking them.
 
Alendronate sodium tablet is not a hormone.
 
There is more information about osteoporosis at the end of this leaflet.


Who should not take alendronate sodium tablets?

 
Do not take alendronate sodium tablets if you:
 



What should I tell my doctor before using alendronate sodium tablets?

Tell your doctor about all of your medical conditions, including if you:
 


 
Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
 
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.

How should I take alendronate sodium tablets?
 



Do not take alendronate sodium tablets with:
 
Mineral water
Coffee or tea
Juice
 

Alendronate sodium tablets work only if taken on an empty stomach.

Do not chew or suck on a tablet of alendronate sodium.
 
After swallowing your alendronate sodium tablet, wait at least 30 minutes:


Do not lie down until after first food of the day.
 


What should I do if I miss a dose of alendronate sodium tablets or if I take too many?
 


What should I avoid while taking alendronate sodium tablets?



What are the possible side effects of alendronate sodium tablets?

Alendronate sodium tablets may cause problems in your esophagus (the tube that connects the mouth and stomach). (See “What is the most important information I should know about alendronate sodium tablets?”.) These problems include irritation, inflammation, or ulcers of the esophagus, which may sometimes bleed. This may occur especially if you do not drink a full glass of water with alendronate sodium tablets or if you lie down in less than 30 minutes or before your first food of the day.
 


Tell your doctor about any side effect that bothers you or that does not go away.
 
These are not all the side effects with alendronate sodium tablets. Ask your doctor or pharmacist for more information.


How do I store alendronate sodium tablets?


 

General information about using alendronate sodium tablets safely and effectively


Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use alendronate sodium tablets for a condition for which it was not prescribed. Do not give alendronate sodium tablets to other people, even if they have the same symptoms you have. They may harm them.
 
Alendronate sodium tablets are not indicated for use in children.
 
This leaflet is a summary of information about alendronate sodium tablets. If you have any questions or concerns about alendronate sodium tablets or osteoporosis, talk to your doctor, pharmacist, or other health care provider. You can ask your doctor or pharmacist for information about alendronate sodium tablets written for health care providers. For more information, call 1-866-850-2876 (toll-free).

What are the ingredients in alendronate sodium tablets?

Alendronate sodium tablets contain alendronate sodium as the active ingredient and the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycolate, povidone, isopropyl alcohol, and magnesium stearate.
 
What should I know about osteoporosis?
 
Normally your bones are being rebuilt all the time. First, old bone is removed (resorbed). Then a similar amount of new bone is formed. This balanced process keeps your skeleton healthy and strong.
 
Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause, and may also occur in men. In osteoporosis, bone is removed faster than it is formed, so overall bone mass is lost and bones become weaker. Therefore, keeping bone mass is important to keep your bones healthy. In both men and women, osteoporosis may also be caused by certain medicines called corticosteroids.
 
At first, osteoporosis usually has no symptoms, but it can cause fractures (broken bones). Fractures usually cause pain. Fractures of the bones of the spine may not be painful, but over time they can make you shorter. Eventually, your spine can curve and your body can become bent over. Fractures may happen during normal, everyday activity, such as lifting, or from minor injury that would normally not cause bones to break. Fractures most often occur at the hip, spine, or wrist. This can lead to pain, severe disability, or loss of ability to move around (mobility).

Who is at risk for osteoporosis?
 
Many things put people at risk of osteoporosis. The following people have a higher chance of getting osteoporosis:
 
Women who:
 


Men who:
 

People who: 


What can I do to help prevent or treat osteoporosis?
 
In addition to alendronate sodium tablets, your doctor may suggest one or more of the following lifestyle changes:


Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
 
Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 072, India
 
Revised: 12/2008

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablet Bottle)


NDC 65862-327-30
Alendronate Sodium Tablets, USP
10 mg*
PHARMACIST:
Rx only           30 Tablets
AUROBINDO


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 70 mg Blister Carton (12 Unit-of-use)


NDC 65862-329-08
ONCE WEEKLY
Alendronate Sodium Tablets, USP
70 mg*
PHARMACIST:
Rx only           12 Tablets
AUROBINDO


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 70 mg Blister Carton (12 Unit-of-use)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 70 mg Blister Carton (10 x 10 Unit-dose)



ONCE WEEKLY                  NDC 65862-329-10
Alendronate Sodium Tablets, USP
70 mg*
PHARMACIST:
Rx only           100 (10 x 10) Unit-dose Tablets
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 70 mg Blister Carton (10 x 10 Unit-dose)

ALENDRONATE SODIUM 
alendronate sodium   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65862-327
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONIC ACID 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
POVIDONE K30  
ISOPROPYL ALCOHOL  
MAGNESIUM STEARATE  
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND (Biconvex) Size 5mm
Flavor Imprint Code F;18
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 65862-327-30 30 TABLET In 1 BOTTLE None
2 65862-327-01 100 TABLET In 1 BOTTLE None
3 65862-327-99 1000 TABLET In 1 BOTTLE None
4 65862-327-10 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK (65862-327-10)
4 65862-327-10 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (65862-327-10)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090124 08/04/2008

ALENDRONATE SODIUM 
alendronate sodium   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65862-328
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONIC ACID 35 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
POVIDONE K30  
ISOPROPYL ALCOHOL  
MAGNESIUM STEARATE  
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (Biconvex) Size 10mm
Flavor Imprint Code F;19
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 65862-328-04 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK (65862-328-04)
1 65862-328-04 4 TABLET In 1 BLISTER PACK This package is contained within the CARTON (65862-328-04)
2 65862-328-08 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK (65862-328-04)
2 65862-328-04 4 TABLET In 1 BLISTER PACK This package is contained within the CARTON (65862-328-08)
3 65862-328-10 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK (65862-328-10)
3 65862-328-10 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (65862-328-10)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090124 08/04/2008

ALENDRONATE SODIUM 
alendronate sodium   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65862-329
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONIC ACID 70 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
POVIDONE K30  
ISOPROPYL ALCOHOL  
MAGNESIUM STEARATE  
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (Biconvex) Size 13mm
Flavor Imprint Code F;21
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 65862-329-04 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK (65862-329-04)
1 65862-329-04 4 TABLET In 1 BLISTER PACK This package is contained within the CARTON (65862-329-04)
2 65862-329-08 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK (65862-329-04)
2 65862-329-04 4 TABLET In 1 BLISTER PACK This package is contained within the CARTON (65862-329-08)
3 65862-329-10 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK (65862-329-10)
3 65862-329-10 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (65862-329-10)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090124 08/04/2008

Labeler - Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 MANUFACTURE
Revised: 08/2009 Aurobindo Pharma Limited