Terbinafine Hydrochloride

Product NDC
70934-947
11-digit product format
709340947
Labeler code
70934
Product ID
70934-947_d722fcda-a6f2-18ba-e053-2a95a90a7de8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA077714
Marketing category
ANDA
Marketing start
2022-02-03
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-947-457093409474545 TABLET in 1 BOTTLE, PLASTIC (70934-947-45) 45 tablet2022-02-030000-00-00NoNoCurrent