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| NDC | 65841-712-01, 65841-712-10, 65841-713-01, 65841-713-10, 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 |
| Set ID | 5525c364-3574-4029-89dc-1efc6d85c03c |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA090411 |
- SPL UNCLASSIFIED SECTION
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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
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INGREDIENTS AND APPEARANCE
ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-712 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE 0.25 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090411 09/23/2009 ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-713 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE 0.5 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090411 09/23/2009 ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-714 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE 1 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090411 09/23/2009 ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-715 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE 2 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090411 09/23/2009 ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-716 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE 3 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090411 09/23/2009 ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-717 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE 4 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090411 09/23/2009 ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-718 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE 5 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090411 09/23/2009 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare 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)