Ropinirole Hydrochloride (Page 9 of 9)

Principal Display Panel

NDC; 51655-360-26

Label
(click image for full-size original)
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-360(NDC:43547-268)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) ROPINIROLE 0.25 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
LECITHIN, SOYBEAN
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (white) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code 972;HH
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-360-26 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078110 05/28/2020
Labeler — Northwind Pharmaceuticals (036986393)
Registrant — Northwind Pharmaceuticals (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals 036986393 repack (51655-360)

Revised: 12/2021 Northwind Pharmaceuticals

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