NDC Code(s) : 62135-572-30, 62135-572-90
Packager : Chartwell RX, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TERBINAFINETerbinafine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-572
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TERBINAFINE HYDROCHLORIDE(UNII: 012C11ZU6G)
(TERBINAFINE - UNII:G7RIW8S0XP) 		TERBINAFINE250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLCELLULOSE, UNSPECIFIED(UNII: Z944H5SN0H)
Product Characteristics
Color white (off-white) Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code CE;45
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62135-572-3030 in 1 BOTTLE Type 0: Not a Combination Product03/08/2022
2NDC:62135-572-9090 in 1 BOTTLE Type 0: Not a Combination Product03/08/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078199 07/02/2007

LABELER - Chartwell RX, LLC(079394054)

REGISTRANT - Chartwell Pharmaceuticals Congers, LLC(118673447)

Establishment
Name Address ID/FEI Business Operations
Chartwell Pharmaceuticals Congers, LLC 118673447 analysis(62135-572), label(62135-572), manufacture(62135-572), pack(62135-572)

PRINCIPAL DISPLAY PANEL

Terbinafine Tablets, USP 250 mg - NDC 62135-572-30 - 30 Tablet Label

Terbinafine Tablets, USP 250 mg - NDC 62135-572-30 - 30 Tablet Label

Terbinafine Tablets, USP 250 mg - NDC 62135-572-90 - 90 Tablet Label

Terbinafine Tablets, USP 250 mg - NDC 62135-572-30 - 30 Tablet Label