AMLODIPINE BESYLATE  - amlodipine besylate tablet 
Aurobindo Pharma Limited

----------

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 2.5 mg Bulk Tablet Label


9000 Tablets
 
Batch :
 
Mfg :
 
Expriy :
 
To be repacked within six months from the date of manufacturing
 
NDC 65862-101-91

BULK SHIPMENT
PLEASE HANDLE CAREFULLY
 
Rx only
 
Amlodipine Besylate Tablets, USP 2.5 mg*
 
*Each tablet contains: Amlodipine besylate USP equivalent to 2.5 mg amlodipine.

CAUTION:
FOR REPACKING ONLY
 
Store at 20º to 25ºC (68º to 77ºF); excursions permitted to
15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].
 
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India
 
M.L.No.: 19/HD/AP/95/F/R
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 2.5 mg Bulk Tablet Label

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 mg Bulk Tablet Label


6000 Tablets
 
Batch :
 
Mfg :
 
Expriy :
 
To be repacked within six months from the date of manufacturing
 
NDC 65862-102-61
 
BULK SHIPMENT
PLEASE HANDLE CAREFULLY
 
Rx only
 
Amlodipine Besylate Tablets, USP 5 mg*
 
*Each tablet contains: Amlodipine besylate USP equivalent to 5 mg amlodipine.
 
CAUTION: FOR REPACKING ONLY
 
Store at 20º to 25ºC (68º to 77ºF); excursions permitted to
15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].
 
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India
 
M.L.No.: 19/HD/AP/95/F/R
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 mg Bulk Tablet Label

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 10 mg Bulk Tablet Label


3000 Tablets 
 
Batch :
 
Mfg :
 
Expriy :
 
To be repacked within six months from the date of manufacturing
 
NDC 65862-103-39
 
BULK SHIPMENT
PLEASE HANDLE CAREFULLY
 
Rx only
 
Amlodipine Besylate Tablets, USP 10 mg*
 
*Each tablet contains: Amlodipine besylate USP equivalent to 10 mg amlodipine.
 
CAUTION: FOR REPACKING ONLY
 
Store at 20º to 25ºC (68º to 77ºF); excursions permitted to
15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].
 
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India
 
M.L.No.: 19/HD/AP/95/F/R
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 10 mg Bulk Tablet Label

AMLODIPINE BESYLATE 
amlodipine besylate tablet
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:65862-101
Route of AdministrationNOT APPLICABLEDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE2.5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITE (White to Off-white) Score no score
ShapeROUND (Flat, Bevel Edged) Size6mm
FlavorImprint Code C;57
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:65862-101-919000 TABLET (9000 TABLET) in 1 BAGNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Drug for Further Processing07/17/2007

AMLODIPINE BESYLATE 
amlodipine besylate tablet
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:65862-102
Route of AdministrationNOT APPLICABLEDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITE (White to Off-white) Score no score
ShapeOVAL (Barrel Shaped, Flat, Bevel Edged) Size8mm
FlavorImprint Code C;58
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:65862-102-616000 TABLET (6000 TABLET) in 1 BAGNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Drug for Further Processing07/17/2007

AMLODIPINE BESYLATE 
amlodipine besylate tablet
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:65862-103
Route of AdministrationNOT APPLICABLEDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITE (White to Off-white) Score no score
ShapeROUND (Flat, Bevel Edged) Size10mm
FlavorImprint Code C;59
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:65862-103-393000 TABLET (3000 TABLET) in 1 BAGNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Drug for Further Processing07/17/2007

Labeler - Aurobindo Pharma Limited (650082092)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited918917642MANUFACTURE, MANUFACTURE, MANUFACTURE, ANALYSIS, ANALYSIS, ANALYSIS

Revised: 02/2012 Aurobindo Pharma Limited