terbinafine hydrochloride

Product NDC
68071-2426
11-digit product format
680712426
Labeler code
68071
Product ID
68071-2426_c365c50e-cff9-116e-e053-2995a90ae0ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terbinafine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078163
Marketing category
ANDA
Marketing start
2020-10-01
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2426-32023-01-30C16284748780-1f386c649-b407-0266-e053-dadaa90a7c1ac365c50e-cff8-116e-e053-2995a90ae0ff

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2426TERBINAFINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210529_c365c50e-cff8-116e-e053-2995a90ae0ff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2426-36807124260330 TABLET in 1 BOTTLE, PLASTIC (68071-2426-3) 30 tablet2021-05-280000-00-00NoNoCurrent