NDC Code 64679-177-04 - Ropinirole Hydrochloride

NDC Code(s) : 64679-154-01, 64679-154-02, 64679-154-03, 64679-154-04, 64679-155-01, 64679-155-02, 64679-155-03, 64679-155-04, 64679-171-01, 64679-171-02, 64679-171-03, 64679-171-04, 64679-172-01, 64679-172-02, 64679-172-03, 64679-172-04, 64679-174-01, 64679-174-02, 64679-174-03, 64679-174-04, 64679-175-01, 64679-175-02, 64679-175-03, 64679-175-04, 64679-177-01, 64679-177-02, 64679-177-03, 64679-177-04
Packager : Wockhardt USA LLC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ROPINIROLE HYDROCHLORIDEropinirole hydrochloride TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64679-154
Route of Administration	ORAL	DEA Schedule

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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (white)	Score	no score
Shape	HEXAGON (6 SIDED) (irregular hexagonal)	Size	8 mm
Flavor		Imprint Code	W;154
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-154-01	30 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
2	NDC:64679-154-02	100 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
3	NDC:64679-154-03	500 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
4	NDC:64679-154-04	10 in 1 CARTON	29/05/2008
4		10 in 1 BLISTER PACK Type 0: Not a Combination Product	29/05/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079050	05/29/2008

LABELER - Wockhardt USA LLC.(170508365)

REGISTRANT - Wockhardt USA LLC.(170508365)

Establishment
Name	Address	ID/FEI	Business Operations
Wockhardt Limited		676257570	ANALYSIS(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), LABEL(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), MANUFACTURE(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), PACK(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177)

INGREDIENTS AND APPEARANCE

ROPINIROLE HYDROCHLORIDEropinirole hydrochloride TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64679-155
Route of Administration	ORAL	DEA Schedule

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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (yellow)	Score	no score
Shape	HEXAGON (6 SIDED) (irregular hexagonal)	Size	8 mm
Flavor		Imprint Code	W;155
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-155-01	30 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
2	NDC:64679-155-02	100 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
3	NDC:64679-155-03	500 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
4	NDC:64679-155-04	10 in 1 CARTON	29/05/2008
4		10 in 1 BLISTER PACK Type 0: Not a Combination Product	29/05/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079050	05/29/2008

LABELER - Wockhardt USA LLC.(170508365)

REGISTRANT - Wockhardt USA LLC.(170508365)

Establishment
Name	Address	ID/FEI	Business Operations
Wockhardt Limited		676257570	ANALYSIS(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), LABEL(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), MANUFACTURE(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), PACK(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177)

INGREDIENTS AND APPEARANCE

ROPINIROLE HYDROCHLORIDEropinirole hydrochloride TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64679-171
Route of Administration	ORAL	DEA Schedule

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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
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 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN (green)	Score	no score
Shape	HEXAGON (6 SIDED) (irregular hexagonal)	Size	8 mm
Flavor		Imprint Code	W;171
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-171-01	30 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
2	NDC:64679-171-02	100 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
3	NDC:64679-171-03	500 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
4	NDC:64679-171-04	10 in 1 CARTON	29/05/2008
4		10 in 1 BLISTER PACK Type 0: Not a Combination Product	29/05/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079050	05/29/2008

LABELER - Wockhardt USA LLC.(170508365)

REGISTRANT - Wockhardt USA LLC.(170508365)

Establishment
Name	Address	ID/FEI	Business Operations
Wockhardt Limited		676257570	ANALYSIS(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), LABEL(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), MANUFACTURE(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), PACK(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177)

INGREDIENTS AND APPEARANCE

ROPINIROLE HYDROCHLORIDEropinirole hydrochloride TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64679-172
Route of Administration	ORAL	DEA Schedule

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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK (pale yellowish pink)	Score	no score
Shape	HEXAGON (6 SIDED) (irregular hexagonal)	Size	8 mm
Flavor		Imprint Code	W;172
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-172-01	30 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
2	NDC:64679-172-02	100 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
3	NDC:64679-172-03	500 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
4	NDC:64679-172-04	10 in 1 CARTON	29/05/2008
4		10 in 1 BLISTER PACK Type 0: Not a Combination Product	29/05/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079050	05/29/2008

LABELER - Wockhardt USA LLC.(170508365)

REGISTRANT - Wockhardt USA LLC.(170508365)

Establishment
Name	Address	ID/FEI	Business Operations
Wockhardt Limited		676257570	ANALYSIS(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), LABEL(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), MANUFACTURE(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), PACK(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177)

INGREDIENTS AND APPEARANCE

ROPINIROLE HYDROCHLORIDEropinirole hydrochloride TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64679-174
Route of Administration	ORAL	DEA Schedule

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
CARMINIC ACID(UNII: CID8Z8N95N)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	PURPLE (purple)	Score	no score
Shape	HEXAGON (6 SIDED) (irregular hexagonal)	Size	8 mm
Flavor		Imprint Code	W;174
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-174-01	30 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
2	NDC:64679-174-02	100 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
3	NDC:64679-174-03	500 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
4	NDC:64679-174-04	10 in 1 CARTON	29/05/2008
4		10 in 1 BLISTER PACK Type 0: Not a Combination Product	29/05/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079050	05/29/2008

LABELER - Wockhardt USA LLC.(170508365)

REGISTRANT - Wockhardt USA LLC.(170508365)

Establishment
Name	Address	ID/FEI	Business Operations
Wockhardt Limited		676257570	ANALYSIS(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), LABEL(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), MANUFACTURE(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), PACK(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177)

INGREDIENTS AND APPEARANCE

ROPINIROLE HYDROCHLORIDEropinirole hydrochloride TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64679-175
Route of Administration	ORAL	DEA Schedule

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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (brown)	Score	no score
Shape	HEXAGON (6 SIDED) (irregular hexagonal)	Size	8 mm
Flavor		Imprint Code	W;175
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-175-01	30 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
2	NDC:64679-175-02	100 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
3	NDC:64679-175-03	500 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
4	NDC:64679-175-04	10 in 1 CARTON	29/05/2008
4		10 in 1 BLISTER PACK Type 0: Not a Combination Product	29/05/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079050	05/29/2008

LABELER - Wockhardt USA LLC.(170508365)

REGISTRANT - Wockhardt USA LLC.(170508365)

Establishment
Name	Address	ID/FEI	Business Operations
Wockhardt Limited		676257570	ANALYSIS(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), LABEL(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), MANUFACTURE(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), PACK(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177)

INGREDIENTS AND APPEARANCE

ROPINIROLE HYDROCHLORIDEropinirole hydrochloride TABLET, FILM COATED

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64679-177
Route of Administration	ORAL	DEA Schedule

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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (blue)	Score	no score
Shape	HEXAGON (6 SIDED) (irregular hexagonal)	Size	8 mm
Flavor		Imprint Code	W;177
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-177-01	30 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
2	NDC:64679-177-02	100 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
3	NDC:64679-177-03	500 in 1 BOTTLE Type 0: Not a Combination Product	29/05/2008
4	NDC:64679-177-04	10 in 1 CARTON	29/05/2008
4		10 in 1 BLISTER PACK Type 0: Not a Combination Product	29/05/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079050	05/29/2008

LABELER - Wockhardt USA LLC.(170508365)

REGISTRANT - Wockhardt USA LLC.(170508365)

Establishment
Name	Address	ID/FEI	Business Operations
Wockhardt Limited		676257570	ANALYSIS(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), LABEL(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), MANUFACTURE(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177), PACK(64679-154, 64679-155, 64679-171, 64679-172, 64679-174, 64679-175, 64679-177)

PRINCIPAL DISPLAY PANEL

DRUG: Ropinirole Hydrochloride

GENERIC: Ropinirole tablets

DOSAGE: Film-coated tablets

ADMINSTRATION: Oral

NDC: 64679-154-01

STRENGTH: 0.25 mg

COLOR: White

SHAPE: hexagonal shaped

SCORE: no score

SIZE: 8 mm

IMPRINT: W;154

QTY: 30 Tablets

DRUG: Ropinirole Hydrochloride

GENERIC: Ropinirole tablets

DOSAGE: Film-coated tablets

ADMINSTRATION: Oral

NDC: 64679-155-01

STRENGTH: 0.5 mg

COLOR: Yellow

SHAPE: hexagonal shaped

SCORE: no score

SIZE: 8 mm

IMPRINT: W;155

QTY: 30 Tablets

DRUG: Ropinirole Hydrochloride

GENERIC: Ropinirole tablets

DOSAGE: Film-coated tablets

ADMINSTRATION: Oral

NDC: 64679-171-01

STRENGTH: 1 mg

COLOR: Green

SHAPE: hexagonal shaped

SCORE: no score

SIZE: 8 mm

IMPRINT: W;171

QTY: 30 Tablets

DRUG: Ropinirole Hydrochloride

GENERIC: Ropinirole tablets

DOSAGE: Film-coated tablets

ADMINSTRATION: Oral

NDC: 64679-172-01

STRENGTH: 2 mg

COLOR: Pink

SHAPE: hexagonal shaped

SCORE: no score

SIZE: 8 mm

IMPRINT: W;172

QTY: 30 Tablets

DRUG: Ropinirole Hydrochloride

GENERIC: Ropinirole tablets

DOSAGE: Film-coated tablets

ADMINSTRATION: Oral

NDC: 64679-174-01

STRENGTH: 3 mg

COLOR: Purple

SHAPE: hexagonal shaped

SCORE: no score

SIZE: 8 mm

IMPRINT: W;174

QTY: 30 Tablets

DRUG: Ropinirole Hydrochloride

GENERIC: Ropinirole tablets

DOSAGE: Film-coated tablets

ADMINSTRATION: Oral

NDC: 64679-175-01

STRENGTH: 4 mg

COLOR: Brown

SHAPE: hexagonal shaped

SCORE: no score

SIZE: 8 mm

IMPRINT: W;175

QTY: 30 Tablets

DRUG: Ropinirole Hydrochloride

GENERIC: Ropinirole tablets

DOSAGE: Film-coated tablets

ADMINSTRATION: Oral

NDC: 64679-177-01

STRENGTH: 5 mg

COLOR: Blue

SHAPE: hexagonal shaped

SCORE: no score

SIZE: 8 mm

IMPRINT: W;177

QTY: 30 Tablets

NDC 64679-177-04
API & Excipient Details

Ropinirole Hydrochloride marketed by Wockhardt USA LLC. under NDC Code 64679-177-04

INGREDIENTS AND APPEARANCE

INGREDIENTS AND APPEARANCE

INGREDIENTS AND APPEARANCE

INGREDIENTS AND APPEARANCE

INGREDIENTS AND APPEARANCE

INGREDIENTS AND APPEARANCE

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 64679-177-04 API & Excipient Details

Ropinirole Hydrochloride marketed by Wockhardt USA LLC. under NDC Code 64679-177-04

INGREDIENTS AND APPEARANCE

INGREDIENTS AND APPEARANCE

INGREDIENTS AND APPEARANCE

INGREDIENTS AND APPEARANCE

INGREDIENTS AND APPEARANCE

INGREDIENTS AND APPEARANCE

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 64679-177-04
API & Excipient Details