Terbinafine Hydrochloride (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

63187-213-30
(click image for full-size original)
TERBINAFINE HYDROCHLORIDE
terbinafine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-213(NDC:31722-209)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE 250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 209;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-213-45 45 TABLET in 1 BOTTLE None
2 NDC:63187-213-30 30 TABLET in 1 BOTTLE None
3 NDC:63187-213-60 60 TABLET in 1 BOTTLE None
4 NDC:63187-213-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077533 01/01/2011
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (63187-213), RELABEL (63187-213)

Revised: 10/2022 Proficient Rx LP

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