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FDA Drug information

Ropinirole hydrochloride

Read time: 1 mins
Marketing start date: 20 Jul 2024

Summary of product characteristics


Effective Time

20221105

Version

7

Spl Product Data Elements

ropinirole hydrochloride ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE ROPINIROLE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE WHITE ROUND ZF22 ropinirole hydrochloride ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE ROPINIROLE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE FERRIC OXIDE RED CELLULOSE, MICROCRYSTALLINE YELLOW ROUND ZF23 ropinirole hydrochloride ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE ROPINIROLE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE GREEN ROUND ZF24 ropinirole hydrochloride ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE ROPINIROLE CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE FERRIC OXIDE RED CELLULOSE, MICROCRYSTALLINE PINK ROUND ZF25 ropinirole hydrochloride ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE ROPINIROLE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE CARMINIC ACID PURPLE ROUND ZF42 ropinirole hydrochloride ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE ROPINIROLE CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE FERRIC OXIDE RED CELLULOSE, MICROCRYSTALLINE FERROSOFERRIC OXIDE BROWN ROUND ZF43 ropinirole hydrochloride ropinirole hydrochloride ROPINIROLE HYDROCHLORIDE ROPINIROLE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE BLUE ROUND ZF26

Application Number

ANDA090411

Brand Name

Ropinirole hydrochloride

Generic Name

ropinirole hydrochloride

Product Ndc

65841-712

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

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 hcl tablets, 0.25 mg ropinirole hcl tablets, 0.5 mg ropinirole hcl tablets, 1 mg ropinirole hcl tablets, 2 mg ropinirole hcl tablets, 3 mg ropinirole hcl tablets, 4 mg ropinirole hcl tablets, 5 mg

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