Terbinafine Hydrochloride

Product NDC
51672-2083
11-digit product format
516722083
Labeler code
51672
Product ID
51672-2083_369cabfd-6c6a-40b4-b3d7-45a871b9964c
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA077511
Marketing category
ANDA
Marketing start
2007-07-02
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
1 g/100g
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
51672-2083-82024-01-30C16284748780-11030e365-582a-111a-e063-dadaa90a10e23639d7f5-fee5-489c-9916-9a235d283830

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2083TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1Legacy NDC20210304_3639d7f5-fee5-489c-9916-9a235d283830.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2083-8516722083081 TUBE in 1 CARTON (51672-2083-8) > 12 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent