DailyMed - ROPINIROLE HYDROCHLORIDE tablet, film coated

NDC Code(s): 65841-712-01, 65841-712-10, 65841-713-01, 65841-713-10, view more
65841-714-01, 65841-714-10, 65841-715-01, 65841-715-10, 65841-716-01, 65841-716-10, 65841-717-01, 65841-717-10, 65841-718-01, 65841-718-10
Packager: Zydus Lifesciences Limited

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

Drug Label Information

Updated November 5, 2022

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SPL UNCLASSIFIED SECTION
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

INGREDIENTS AND APPEARANCE

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
Packaging
1	NDC:65841-712-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009
2	NDC:65841-712-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009

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

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
Packaging
1	NDC:65841-713-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009
2	NDC:65841-713-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009

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

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
Packaging
1	NDC:65841-714-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009
2	NDC:65841-714-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009

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

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
Packaging
1	NDC:65841-715-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009
2	NDC:65841-715-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009

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

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
Packaging
1	NDC:65841-716-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009
2	NDC:65841-716-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009

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

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
Packaging
1	NDC:65841-717-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009
2	NDC:65841-717-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009

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

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
Packaging
1	NDC:65841-718-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009
2	NDC:65841-718-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2009

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

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)

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Published Date (What is this?)	Version	Files
Nov 9, 2022	7 (current)	download
Sep 21, 2020	6	download
Dec 6, 2019	5	download
Dec 20, 2017	4	download
May 6, 2011	3	download
Oct 30, 2009	2	download

	RxCUI	RxNorm NAME	RxTTY
1	283858	rOPINIRole HCl 3 MG Oral Tablet	PSN
2	283858	ropinirole 3 MG Oral Tablet	SCD
3	283858	ropinirole 3 MG (as ropinirole hydrochloride) Oral Tablet	SY
4	312845	rOPINIRole HCl 0.25 MG Oral Tablet	PSN
5	312845	ropinirole 0.25 MG Oral Tablet	SCD
6	312845	ropinirole 0.25 MG (as ropinirole hydrochloride) Oral Tablet	SY
7	312846	rOPINIRole HCl 0.5 MG Oral Tablet	PSN
8	312846	ropinirole 0.5 MG Oral Tablet	SCD
9	312846	ropinirole 0.5 MG (as ropinirole hydrochloride) Oral Tablet	SY
10	312847	rOPINIRole HCl 2 MG Oral Tablet	PSN
11	312847	ropinirole 2 MG Oral Tablet	SCD
12	312847	ropinirole 2 MG (as ropinirole hydrochloride) Oral Tablet	SY
13	312849	rOPINIRole HCl 5 MG Oral Tablet	PSN
14	312849	ropinirole 5 MG Oral Tablet	SCD
15	312849	ropinirole 5 MG (as ropinirole hydrochloride) Oral Tablet	SY
16	314208	rOPINIRole HCl 1 MG Oral Tablet	PSN
17	314208	ropinirole 1 MG Oral Tablet	SCD
18	314208	ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet	SY
19	562704	rOPINIRole HCl 4 MG Oral Tablet	PSN
20	562704	ropinirole 4 MG Oral Tablet	SCD
21	562704	ropinirole 4 MG (as ropinirole hydrochloride) Oral Tablet	SY

Label: ROPINIROLE HYDROCHLORIDE tablet, film coated

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	NDC
1	65841-712-01
2	65841-712-10
3	65841-713-01
4	65841-713-10
5	65841-714-01
6	65841-714-10
7	65841-715-01
8	65841-715-10
9	65841-716-01
10	65841-716-10
11	65841-717-01
12	65841-717-10
13	65841-718-01
14	65841-718-10

Label: ROPINIROLE HYDROCHLORIDE tablet, film coated

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

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Safety

Related Resources

More Info on this Drug

ROPINIROLE HYDROCHLORIDE tablet, film coated

Number of versions: 6

ROPINIROLE HYDROCHLORIDE tablet, film coated

ROPINIROLE HYDROCHLORIDE tablet, film coated

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ROPINIROLE HYDROCHLORIDE tablet, film coated

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