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

Pramipexole Dihydrochloride ER Tablets image 02

NDC 70771-1330-3

Pramipexole Dihydrochloride Extended-release Tablets, 1.5 mg

Rx only

30 tablets

Pramipexole Dihydrochloride ER Tablets image 03

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

Pramipexole Dihydrochloride ER Tablets image 04

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

Pramipexole Dihydrochloride ER Tablets image 05

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)

PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL