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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE(UNII: D7ZD41RZI9)
(ROPINIROLE - UNII:030PYR8953) 		ROPINIROLE0.25 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64679-154-0130 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
2NDC:64679-154-02100 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
3NDC:64679-154-03500 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
4NDC:64679-154-0410 in 1 CARTON 29/05/2008
410 in 1 BLISTER PACK Type 0: Not a Combination Product29/05/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE(UNII: D7ZD41RZI9)
(ROPINIROLE - UNII:030PYR8953) 		ROPINIROLE0.5 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64679-155-0130 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
2NDC:64679-155-02100 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
3NDC:64679-155-03500 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
4NDC:64679-155-0410 in 1 CARTON 29/05/2008
410 in 1 BLISTER PACK Type 0: Not a Combination Product29/05/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE(UNII: D7ZD41RZI9)
(ROPINIROLE - UNII:030PYR8953) 		ROPINIROLE1 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64679-171-0130 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
2NDC:64679-171-02100 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
3NDC:64679-171-03500 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
4NDC:64679-171-0410 in 1 CARTON 29/05/2008
410 in 1 BLISTER PACK Type 0: Not a Combination Product29/05/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE(UNII: D7ZD41RZI9)
(ROPINIROLE - UNII:030PYR8953) 		ROPINIROLE2 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64679-172-0130 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
2NDC:64679-172-02100 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
3NDC:64679-172-03500 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
4NDC:64679-172-0410 in 1 CARTON 29/05/2008
410 in 1 BLISTER PACK Type 0: Not a Combination Product29/05/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE(UNII: D7ZD41RZI9)
(ROPINIROLE - UNII:030PYR8953) 		ROPINIROLE3 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64679-174-0130 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
2NDC:64679-174-02100 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
3NDC:64679-174-03500 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
4NDC:64679-174-0410 in 1 CARTON 29/05/2008
410 in 1 BLISTER PACK Type 0: Not a Combination Product29/05/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE(UNII: D7ZD41RZI9)
(ROPINIROLE - UNII:030PYR8953) 		ROPINIROLE4 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64679-175-0130 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
2NDC:64679-175-02100 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
3NDC:64679-175-03500 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
4NDC:64679-175-0410 in 1 CARTON 29/05/2008
410 in 1 BLISTER PACK Type 0: Not a Combination Product29/05/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE(UNII: D7ZD41RZI9)
(ROPINIROLE - UNII:030PYR8953) 		ROPINIROLE5 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64679-177-0130 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
2NDC:64679-177-02100 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
3NDC:64679-177-03500 in 1 BOTTLE Type 0: Not a Combination Product29/05/2008
4NDC:64679-177-0410 in 1 CARTON 29/05/2008
410 in 1 BLISTER PACK Type 0: Not a Combination Product29/05/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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

0.25 mg-30T

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

0.25 mg-30T

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

0.25 mg-30T

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

0.25 mg-30T

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

0.25 mg-30T

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

0.25 mg-30T

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

0.25 mg-30T