TERBINAFINE HYDROCHLORIDE (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Terbinafine Hydrochloride

GENERIC: Terbinafine Hydrochloride

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-743-01

STRENGTH: 250 mg

COLOR: White

SHAPE: Round (Bi-convex, beveled)

SCORE: no score

SIZE: 11 mm

IMPRINT: W;743

QTY: 30 Tablets

30T-Label
(click image for full-size original)
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-743
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
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score no score
Shape ROUND (bi-convex, bevelled) Size 11mm
Flavor Imprint Code W;743
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-743-01 30 TABLET in 1 BOTTLE None
2 NDC:64679-743-03 100 TABLET in 1 BOTTLE None
3 NDC:64679-743-02 1000 TABLET in 1 BOTTLE None
4 NDC:64679-743-04 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (64679-743-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078229 07/02/2007
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Wockhardt Limited (650069115)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 676257570 ANALYSIS (64679-743), MANUFACTURE (64679-743), LABEL (64679-743), PACK (64679-743)

Revised: 11/2019 Wockhardt USA LLC.

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