TERBINAFINE

Product NDC
72189-243
11-digit product format
721890243
Labeler code
72189
Product ID
72189-243_2c28596f-8fc8-42e5-e063-6294a90a0ad6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TERBINAFINE
Dosage form
TABLET
Route
ORAL
Labeler
direct rx
Application
ANDA078297
Marketing category
ANDA
Marketing start
2021-07-23
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
G7RIW8S0XPTERBINAFINE91161-71-6TERBINAFINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-243-307218902433030 TABLET in 1 BOTTLE (72189-243-30) 30 tablet2021-07-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TERBINAFINEdirect rx2025-01-20HUMAN PRESCRIPTION DRUG LABEL2