PRAMIPEXOLE DIHYDROCHLORIDE- pramipexole dihydrochloride tablet
Zydus Lifesciences Limited

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PRAMIPEXOLE DIHYDROCHLORIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-734-10 in bottle of 1000 tablets

Pramipexole Dihydrochloride Tablets, 0.125 mg

Rx only

1000 tablets

Pramipexole Dihydrochloride Tablets, 0.125 mg

NDC 65841-735-10 in bottle of 1000 tablets

Pramipexole Dihydrochloride Tablets, 0.25 mg

Rx only

1000 tablets

Pramipexole Dihydrochloride Tablets, 0.25 mg

NDC 65841-736-10 in bottle of 1000 tablets

Pramipexole Dihydrochloride Tablets, 0.5 mg

Rx only

1000 tablets

Pramipexole Dihydrochloride Tablets , 0.5 mg

NDC 65841-737-10 in bottle of 1000 tablets

Pramipexole Dihydrochloride Tablets, 1 mg

Rx only

1000 tablets

Pramipexole Dihydrochloride Tablets , 1 mg

NDC 65841-738-16 in bottle of 90 tablets

Pramipexole Dihydrochloride Tablets, 1.5 mg

Rx only

90 tablets

Pramipexole Dihydrochloride Tablets , 1.5 mmg

NDC 65841-844-16 in bottle of 90 tablets

Pramipexole Dihydrochloride Tablets, 0.75 mg

Rx only

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-734
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)	PRAMIPEXOLE DIHYDROCHLORIDE	0.125 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	PINK (PINK)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	7mm
Flavor		Imprint Code	P1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-734-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025
2	NDC:65841-734-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025
3	NDC:65841-734-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078920	07/10/2010	05/05/2025

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-735
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)	PRAMIPEXOLE DIHYDROCHLORIDE	0.25 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	BLUE (PALE BLUE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	P2
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-735-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025
2	NDC:65841-735-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025
3	NDC:65841-735-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078920	07/10/2010	05/05/2025

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-736
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)	PRAMIPEXOLE DIHYDROCHLORIDE	0.5 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	PURPLE (LAVENDER)	Score	2 pieces
Shape	CAPSULE (CAPSULE)	Size	8mm
Flavor		Imprint Code	P;3
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-736-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025
2	NDC:65841-736-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025
3	NDC:65841-736-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078920	07/10/2010	05/05/2025

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-737
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)	PRAMIPEXOLE DIHYDROCHLORIDE	1 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	ORANGE (LIGHT PEACH TO PEACH)	Score	2 pieces
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	P4
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-737-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025
2	NDC:65841-737-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025
3	NDC:65841-737-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078920	07/10/2010	05/05/2025

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-738
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	YELLOW (YELLOW)	Score	2 pieces
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	P5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-738-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025
2	NDC:65841-738-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025
3	NDC:65841-738-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2010	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078920	07/10/2010	05/05/2025

PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-844
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	YELLOW (YELLOW)	Score	2 pieces
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	P5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-844-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2022	03/25/2025
2	NDC:65841-844-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/30/2022	03/25/2025
3	NDC:65841-844-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/30/2022	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078920	11/23/2022	05/05/2025

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-734, 65841-735, 65841-736, 65841-737, 65841-738, 65841-844) , MANUFACTURE(65841-734, 65841-735, 65841-736, 65841-737, 65841-738, 65841-844)

Revised: 5/2025

Document Id: 907cf6a2-5793-4eaf-8bb9-137816d1baa2

Set id: 0ac104bc-8ee9-4602-b1b3-38521342f97c

Version: 11

Effective Time: 20250505

Zydus Lifesciences Limited