Ropinirole Hydrochloride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ropinirole Hydrochloride Tablets 0.25 mg (100 tablets in HDPE bottle)
Each film coated tablet contains: Ropinirole Hydrochloride equivalent to Ropinirole…. 0.25 mg

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ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-166(NDC:23155-121)
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
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
TITANIUM DIOXIDE
HYPROMELLOSES
POLYETHYLENE GLYCOLS
Product Characteristics
Color WHITE Score no score
Shape ROUND (Circular,Biconvex) Size 7mm
Flavor Imprint Code A;109
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-166-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:53217-166-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090429 09/18/2009
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 03/2015 Aidarex Pharmaceuticals LLC

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