ROPINIROLE HYDROCHLORIDE- ropinirole hydrochloride tablet, film coated
Zydus Lifesciences Limited

----------

ROPINIROLE TABELTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-712-01 in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 0.25 mg

100 tablets

NDC 65841-713-01 in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 0.5 mg

100 tablets

NDC 65841-714-01 in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 1 mg

100 tablets

NDC 65841-715-01in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 2 mg

100 tablets

NDC 65841-716-01 in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 3 mg

100 tablets

NDC 65841-717-01 in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 4 mg

100 tablets

NDC 65841-718-01 in bottle of 100 tablets

Ropinirole Hydrochloride Tablets, 5 mg

100 tablets

ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-712
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)	ROPINIROLE	0.25 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	ZF22
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-712-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025
2	NDC:65841-712-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090411	09/23/2009	08/23/2025

ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-713
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)	ROPINIROLE	0.5 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	YELLOW (YELLOW)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	ZF23
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-713-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025
2	NDC:65841-713-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090411	09/23/2009	08/23/2025

ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-714
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)	ROPINIROLE	1 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	GREEN (GREEN)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	ZF24
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-714-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025
2	NDC:65841-714-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090411	09/23/2009	08/23/2025

ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-715
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)	ROPINIROLE	2 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	PINK (PINK)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	ZF25
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-715-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025
2	NDC:65841-715-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090411	09/23/2009	08/23/2025

ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-716
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)	ROPINIROLE	3 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARMINIC ACID (UNII: CID8Z8N95N)

Product Characteristics
Color	PURPLE (PURPLE)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	ZF42
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-716-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025
2	NDC:65841-716-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090411	09/23/2009	08/23/2025

ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-717
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)	ROPINIROLE	4 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	BROWN (BROWN)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	ZF43
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-717-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025
2	NDC:65841-717-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090411	09/23/2009	08/23/2025

ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-718
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)	ROPINIROLE	5 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	BLUE (BLUE)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	ZF26
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-718-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025
2	NDC:65841-718-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090411	09/23/2009	08/23/2025

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-712, 65841-713, 65841-714, 65841-715, 65841-716, 65841-717, 65841-718) , MANUFACTURE(65841-712, 65841-713, 65841-714, 65841-715, 65841-716, 65841-717, 65841-718)

Revised: 8/2025

Document Id: 79da1e00-765b-43a4-95ab-a171f2394eb5

Set id: 5525c364-3574-4029-89dc-1efc6d85c03c

Version: 9

Effective Time: 20250823

Zydus Lifesciences Limited