FDA.reportPublic FDA data

Terbinafine

Product NDC
70518-1191
11-digit product format
705181191
Labeler code
70518
Product ID
70518-1191_d83baf52-9deb-21a9-e053-2a95a90a211e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077533
Marketing category
ANDA
Marketing start
2018-05-14
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
70518-1191-02025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-02025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-12025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-12025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-22025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-22025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-32025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-32025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-42025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-42025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-52025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-52025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-62025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-62025-11-13C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-02024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-02024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-12024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-12024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-22024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-22024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-32024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-32024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-42024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-42024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-52024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-52024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-62024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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
70518-1191-62024-01-30C16284748780-11030e365-23cf-111a-e063-dadaa90a10e2These 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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1191TERBINAFINE TABLET [REMEDYREPACK INC.]9Legacy NDC20220302_80aab848-8739-4259-a092-ed99d0f6a56d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1191-07051811910030 TABLET in 1 BOTTLE, PLASTIC (70518-1191-0) 30 tablet2018-05-140000-00-00NoNoCurrent
70518-1191-17051811910130 TABLET in 1 BLISTER PACK (70518-1191-1) 30 tablet2019-02-080000-00-00NoNoCurrent
70518-1191-27051811910230 TABLET in 1 BLISTER PACK (70518-1191-2) 30 tablet2020-10-130000-00-00NoNoCurrent
70518-1191-37051811910345 TABLET in 1 BOTTLE, PLASTIC (70518-1191-3) 45 tablet2021-10-270000-00-00NoNoCurrent
70518-1191-47051811910490 TABLET in 1 BOTTLE, PLASTIC (70518-1191-4) 90 tablet2021-11-130000-00-00NoNoCurrent
70518-1191-57051811910514 TABLET in 1 BOTTLE, PLASTIC (70518-1191-5) 14 tablet2021-12-090000-00-00NoNoCurrent
70518-1191-67051811910660 TABLET in 1 BOTTLE, PLASTIC (70518-1191-6) 60 tablet2022-02-170000-00-00NoNoCurrent