FDA.reportPublic FDA data

Terbinafine

Product NDC
53002-0550
11-digit product format
530020550
Labeler code
53002
Product ID
53002-0550_fcecd3c8-639d-440c-80d1-b5ade10d6c7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK 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
2021-12-31
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
53002-0550-32025-01-30C16284748780-1f386c649-cf25-0266-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
53002-0550-32023-06-07C16284748780-1f386c649-cf25-0266-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
53002-0550-32023-01-30C16284748780-1f386c649-cf25-0266-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
53002-0550-3Terbinafine30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0550TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20230609_ba6874fa-2bd9-482d-9ffc-8674288d304c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSNba6874fa-2bd9-482d-9ffc-8674288d304c3
313222terbinafine 250 MG Oral TabletSCDba6874fa-2bd9-482d-9ffc-8674288d304c3
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYba6874fa-2bd9-482d-9ffc-8674288d304c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0550-35300205500330 TABLET in 1 BOTTLE (53002-0550-3) 30 tablet2019-01-010000-00-00NoNoCurrent