Ropinirole Hydrochloride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68258-7162-XX

NDC 68258-7162-03

NDC 68258-7162-XX
(click image for full-size original)

ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68258-7162(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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
POLYETHYLENE GLYCOLS
POLYSORBATE 80
TITANIUM DIOXIDE
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:68258-7162-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090429 09/18/2009
Labeler — Dispensing Solutions, Inc. (066070785)
Registrant — PSS World Medical, Inc. (101822682)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 relabel (68258-7162), repack (68258-7162)

Revised: 08/2013 Dispensing Solutions, Inc.

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