Terbinafine Hydrochloride

Product NDC
68071-4578
11-digit product format
680714578
Labeler code
68071
Product ID
68071-4578_bbf19699-c59b-8b74-e053-2a95a90a0df7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077714
Marketing category
ANDA
Marketing start
2010-12-27
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine [CS],Allylamine Antifungal [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4578-36807145780330 TABLET in 1 BOTTLE (68071-4578-3) 30 tablet2018-09-270000-00-00NoNoCurrent