FDA.reportPublic FDA data

Terbinafine Hydrochloride

Product NDC
71335-0257
11-digit product format
713350257
Labeler code
71335
Product ID
71335-0257_e1c0429c-36b3-4dad-81e0-0b53655aadc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077137
Marketing category
ANDA
Marketing start
2014-08-13
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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
71335-0257-12024-01-30C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-22024-01-30C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-32024-01-30C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-42024-01-30C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-52024-01-30C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-62024-01-30C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-72024-01-30C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-82024-01-30C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-12020-02-05C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-22020-02-05C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-32020-02-05C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-42020-02-05C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-52020-02-05C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-62020-02-05C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-72020-02-05C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-82020-02-05C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-12020-01-31C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-22020-01-31C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-32020-01-31C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-42020-01-31C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-52020-01-31C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-62020-01-31C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-72020-01-31C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-82020-01-31C16284748780-19d75b9d0-f3a3-f424-e053-dadaa90a57ceThese 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
71335-0257-1Terbinafine Hydrochloride30 in 1 BOTTLETABLET304
71335-0257-2Terbinafine Hydrochloride60 in 1 BOTTLETABLET604
71335-0257-3Terbinafine Hydrochloride90 in 1 BOTTLETABLET904
71335-0257-4Terbinafine Hydrochloride100 in 1 BOTTLETABLET1004
71335-0257-5Terbinafine Hydrochloride7 in 1 BOTTLETABLET74
71335-0257-6Terbinafine Hydrochloride40 in 1 BOTTLETABLET404
71335-0257-7Terbinafine Hydrochloride45 in 1 BOTTLETABLET454
71335-0257-8Terbinafine Hydrochloride14 in 1 BOTTLETABLET144

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0257-1EA - Each71335-0257b77bc17c-5e94-485c-a10a-a65f5714f7c112018-01-12
71335-0257-2EA - Each71335-02570b2c6564-e591-4e91-8f19-bbe9575665c312018-01-12
71335-0257-3EA - Each71335-025746cc24ed-9494-43ec-aa82-632aaa508d8712018-01-12
71335-0257-4EA - Each71335-0257e54b60e5-f3a4-47cd-ba0c-7acc953a139312018-01-12
71335-0257-5EA - Each71335-0257570a7a4b-000d-4da7-98f5-721ba3c7575a12018-01-12
71335-0257-6EA - Each71335-0257f41ec794-0ec5-4299-819d-ba921665ae3212018-01-12
71335-0257-7EA - Each71335-0257dc022619-b772-406a-a014-ef22601e8d7e12018-01-12
71335-0257-8EA - Each71335-02577f861526-b39e-4ba4-a1cc-2c65ed98190012018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0257TERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]4Legacy NDC, 8 package rows20221206_25ba1266-b7f7-457b-a659-7bdb2eccda5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN25ba1266-b7f7-457b-a659-7bdb2eccda5d4
313222terbinafine 250 MG Oral TabletSCD25ba1266-b7f7-457b-a659-7bdb2eccda5d4
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY25ba1266-b7f7-457b-a659-7bdb2eccda5d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0257-17133502570130 TABLET in 1 BOTTLE (71335-0257-1) 30 tablet2015-06-120000-00-00NoNoCurrent
71335-0257-27133502570260 TABLET in 1 BOTTLE (71335-0257-2) 60 tablet2015-06-120000-00-00NoNoCurrent
71335-0257-37133502570390 TABLET in 1 BOTTLE (71335-0257-3) 90 tablet2015-06-120000-00-00NoNoCurrent
71335-0257-471335025704100 TABLET in 1 BOTTLE (71335-0257-4) 100 tablet2015-06-120000-00-00NoNoCurrent
71335-0257-5713350257057 TABLET in 1 BOTTLE (71335-0257-5) 7 tablet2015-06-120000-00-00NoNoCurrent
71335-0257-67133502570640 TABLET in 1 BOTTLE (71335-0257-6) 40 tablet2015-06-120000-00-00NoNoCurrent
71335-0257-77133502570745 TABLET in 1 BOTTLE (71335-0257-7) 45 tablet2015-06-120000-00-00NoNoCurrent
71335-0257-87133502570814 TABLET in 1 BOTTLE (71335-0257-8) 14 tablet2015-06-120000-00-00NoNoCurrent