FDA.reportPublic FDA data

Terbinafine

Product NDC
68071-2579
11-digit product format
680712579
Labeler code
68071
Product ID
68071-2579_d12be96b-e2dd-b356-e053-2a95a90a1f99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078297
Marketing category
ANDA
Marketing start
2007-07-02
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2579-32025-01-30C16284748780-1f386c64a-49d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992
68071-2579-32023-06-07C16284748780-1f386c64a-49d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992
68071-2579-32023-01-30C16284748780-1f386c64a-49d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2579-3Terbinafine30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2579TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20230609_d12be96b-e2de-b356-e053-2a95a90a1f99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSNd12be96b-e2de-b356-e053-2a95a90a1f992
313222terbinafine 250 MG Oral TabletSCDd12be96b-e2de-b356-e053-2a95a90a1f992
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYd12be96b-e2de-b356-e053-2a95a90a1f992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2579-36807125790330 TABLET in 1 BOTTLE (68071-2579-3) 30 tablet2021-11-190000-00-00NoNoCurrent