Terbinafine Hydrochloride

Product NDC
72162-1595
11-digit product format
721621595
Labeler code
72162
Product ID
72162-1595_f9f34f4d-d49d-4921-9e3e-8b6e2fd16d9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077714
Marketing category
ANDA
Marketing start
2010-12-27
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
012C11ZU6GTERBINAFINE HYDROCHLORIDE78628-80-5TERBINAFINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1595-172162159501100 TABLET in 1 BOTTLE (72162-1595-1) 100 tablet2024-02-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Terbinafine HydrochlorideBryant Ranch Prepack2024-02-07HUMAN PRESCRIPTION DRUG LABEL101