DailyMed - PRAMIPEXOLE DIHYDROCHLORIDE tablet, extended release

NDC Code(s): 70771-1328-2, 70771-1328-3, 70771-1328-4, 70771-1329-2, view more
70771-1329-3, 70771-1329-4, 70771-1330-2, 70771-1330-3, 70771-1330-4, 70771-1331-3, 70771-1332-2, 70771-1332-3, 70771-1332-4, 70771-1333-2, 70771-1333-3, 70771-1333-4, 70771-1334-2, 70771-1334-3, 70771-1334-4
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 13, 2022

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SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1328-3

Pramipexole Dihydrochloride Extended-release Tablets, 0.375 mg

Rx only

30 tablets

NDC 70771-1329-3

Pramipexole Dihydrochloride Extended-release Tablets, 0.75 mg

Rx only

30 tablets

NDC 70771-1330-3

Pramipexole Dihydrochloride Extended-release Tablets, 1.5 mg

Rx only

30 tablets

NDC 70771-1331-3

Pramipexole Dihydrochloride Extended-release Tablets, 2.25 mg

Rx only

30 tablets

NDC 70771-1332-3

Pramipexole Dihydrochloride Extended-release Tablets, 3 mg

Rx only

30 tablets

NDC 70771-1333-3

Pramipexole Dihydrochloride Extended-release Tablets, 3.75 mg

Rx only

30 tablets

NDC 70771-1334-3

Pramipexole Dihydrochloride Extended-release Tablets, 4.5 mg

Rx only

30 tablets

INGREDIENTS AND APPEARANCE

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1328
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)	PRAMIPEXOLE DIHYDROCHLORIDE	0.375 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE) , BROWN (Buff to light brown speckles)	Score	no score
Shape	OVAL (oval)	Size	11mm
Flavor		Imprint Code	474
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1328-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2018
2	NDC:70771-1328-4	10 in 1 CARTON	04/24/2018
2	NDC:70771-1328-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202891	04/24/2018

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1329
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)	PRAMIPEXOLE DIHYDROCHLORIDE	0.75 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE) , BROWN (Buff to light brown speckles)	Score	no score
Shape	OVAL (oval)	Size	11mm
Flavor		Imprint Code	475
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1329-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2018
2	NDC:70771-1329-4	10 in 1 CARTON	04/24/2018
2	NDC:70771-1329-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202891	04/24/2018

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1330
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)	PRAMIPEXOLE DIHYDROCHLORIDE	1.5 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE) , BROWN (Buff to light brown speckles)	Score	no score
Shape	OVAL (oval)	Size	13mm
Flavor		Imprint Code	476
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1330-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2018
2	NDC:70771-1330-4	10 in 1 CARTON	04/24/2018
2	NDC:70771-1330-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202891	04/24/2018

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1332
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)	PRAMIPEXOLE DIHYDROCHLORIDE	3 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE) , BROWN (Buff to light brown speckles)	Score	no score
Shape	OVAL (oval)	Size	13mm
Flavor		Imprint Code	477
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1332-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2018
2	NDC:70771-1332-4	10 in 1 CARTON	04/24/2018
2	NDC:70771-1332-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202891	04/24/2018

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1334
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)	PRAMIPEXOLE DIHYDROCHLORIDE	4.5 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE) , BROWN (Buff to light brown speckles)	Score	no score
Shape	OVAL (oval)	Size	16mm
Flavor		Imprint Code	478
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1334-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2018
2	NDC:70771-1334-4	10 in 1 CARTON	04/24/2018
2	NDC:70771-1334-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202891	04/24/2018

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1331
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)	PRAMIPEXOLE DIHYDROCHLORIDE	2.25 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	WHITE (OFF-WHITE)	Score	no score
Shape	OVAL (OVAL)	Size	13mm
Flavor		Imprint Code	874
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1331-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202891	04/24/2018

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1333
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)	PRAMIPEXOLE DIHYDROCHLORIDE	3.75 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	WHITE (OFF-WHITE)	Score	no score
Shape	OVAL (OVAL)	Size	13mm
Flavor		Imprint Code	875
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1333-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2018
2	NDC:70771-1333-4	10 in 1 CARTON	04/24/2018
2	NDC:70771-1333-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202891	04/24/2018

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1328, 70771-1329, 70771-1330, 70771-1331, 70771-1332, 70771-1333, 70771-1334) , MANUFACTURE(70771-1328, 70771-1329, 70771-1330, 70771-1331, 70771-1332, 70771-1333, 70771-1334)

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Published Date (What is this?)	Version	Files
Oct 18, 2022	5 (current)	download
Sep 16, 2020	4	download
Dec 16, 2019	3	download
May 21, 2018	2	download
Apr 24, 2018	1	download

	RxCUI	RxNorm NAME	RxTTY
1	901534	pramipexole dihydrochloride 4.5 MG 24HR Extended Release Oral Tablet	PSN
2	901534	24 HR pramipexole dihydrochloride 4.5 MG Extended Release Oral Tablet	SCD
3	901534	pramipexole dihydrochloride 4.5 MG 24 HR Extended Release Oral Tablet	SY
4	901541	pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet	PSN
5	901541	24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet	SCD
6	901541	pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet	SY
7	901546	pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral Tablet	PSN
8	901546	24 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral Tablet	SCD
9	901546	pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral Tablet	SY
10	901546	pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral Tablet	SY
11	901550	pramipexole dihydrochloride 1.5 MG 24HR Extended Release Oral Tablet	PSN
12	901550	24 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral Tablet	SCD
13	901550	pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral Tablet	SY
14	901555	pramipexole dihydrochloride 3 MG 24HR Extended Release Oral Tablet	PSN
15	901555	24 HR pramipexole dihydrochloride 3 MG Extended Release Oral Tablet	SCD
16	901555	pramipexole dihydrochloride 3 MG 24 HR Extended Release Oral Tablet	SY
17	1114479	pramipexole dihydrochloride 2.25 MG 24HR Extended Release Oral Tablet	PSN
18	1114479	24 HR pramipexole dihydrochloride 2.25 MG Extended Release Oral Tablet	SCD
19	1114479	pramipexole dihydrochloride 2.25 MG 24 HR Extended Release Oral Tablet	SY
20	1114485	pramipexole dihydrochloride 3.75 MG 24HR Extended Release Oral Tablet	PSN
21	1114485	24 HR pramipexole dihydrochloride 3.75 MG Extended Release Oral Tablet	SCD
22	1114485	pramipexole dihydrochloride 3.75 MG 24 HR Extended Release Oral Tablet	SY

Label: PRAMIPEXOLE DIHYDROCHLORIDE tablet, extended release

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	NDC
1	70771-1328-2
2	70771-1328-3
3	70771-1328-4
4	70771-1329-2
5	70771-1329-3
6	70771-1329-4
7	70771-1330-2
8	70771-1330-3
9	70771-1330-4
10	70771-1331-3
11	70771-1332-2
12	70771-1332-3
13	70771-1332-4
14	70771-1333-2
15	70771-1333-3
16	70771-1333-4
17	70771-1334-2
18	70771-1334-3
19	70771-1334-4

Label: PRAMIPEXOLE DIHYDROCHLORIDE tablet, extended release

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PRAMIPEXOLE DIHYDROCHLORIDE tablet, extended release

Number of versions: 5

PRAMIPEXOLE DIHYDROCHLORIDE tablet, extended release

PRAMIPEXOLE DIHYDROCHLORIDE tablet, extended release

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PRAMIPEXOLE DIHYDROCHLORIDE tablet, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.