Terbinafine (Page 5 of 5)

Terbinafine HCl 250mg Tablets

Label Image
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TERBINAFINE terbinafine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-0550(NDC:65862-079)
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
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND (Biconvex Beveled Edge) Size 11mm
Flavor Imprint Code D;74
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-0550-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078297 07/02/2007
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-0550), REPACK (53002-0550)

Revised: 06/2023 RPK Pharmaceuticals, Inc.

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