FDA.reportPublic FDA data

Terbinafine Hydrochloride

Product NDC
50090-1048
11-digit product format
500901048
Labeler code
50090
Product ID
50090-1048_1d9dab8d-1e3b-4c35-847d-57dbaa8c2ead
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077714
Marketing category
ANDA
Marketing start
2010-12-27
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Terbinafine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G
Rxcui313222

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
50090-1048-02023-02-06C16284748780-1f386c64a-1c0e-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
50090-1048-12023-02-06C16284748780-1f386c64a-1c0e-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
50090-1048-02023-01-30C16284748780-1f386c64a-1c0e-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
50090-1048-12023-01-30C16284748780-1f386c64a-1c0e-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
50090-1048-0Terbinafine Hydrochloride30 in 1 BOTTLETABLET3015
50090-1048-1Terbinafine Hydrochloride90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1048-0EA - Each50090-1048453bc0bf-7418-4b1b-8a40-fd67314b437b12018-11-06
50090-1048-1EA - Each50090-1048ebf26575-438a-4120-8042-074d4a7badf412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1048TERBINAFINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 2 package rows20231101_6605103b-fd71-4438-8496-f48973b98901.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN6605103b-fd71-4438-8496-f48973b9890115
313222terbinafine 250 MG Oral TabletSCD6605103b-fd71-4438-8496-f48973b9890115
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY6605103b-fd71-4438-8496-f48973b9890115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1048-05009010480030 TABLET in 1 BOTTLE (50090-1048-0) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-1048-15009010480190 TABLET in 1 BOTTLE (50090-1048-1) 90 tablet2014-11-280000-00-00NoNoCurrent