FDA.reportPublic FDA data

Terbinafine Hydrochloride

Product NDC
68071-4500
11-digit product format
680714500
Labeler code
68071
Product ID
68071-4500_1a8daeb9-2c25-ccc0-e063-6394a90a9cae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
68071-4500-12022-02-07C16284748780-1d6a99b39-879c-a426-e053-dadaa90af4c2These 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
68071-4500-12022-01-28C16284748780-1d6a99b39-879c-a426-e053-dadaa90af4c2These 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
68071-4500-1Terbinafine Hydrochloride100 in 1 BOTTLETABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4500TERBINAFINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20240612_715cae3e-4e86-48b3-e053-2a95a90afdc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN715cae3e-4e86-48b3-e053-2a95a90afdc25
313222terbinafine 250 MG Oral TabletSCD715cae3e-4e86-48b3-e053-2a95a90afdc25
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY715cae3e-4e86-48b3-e053-2a95a90afdc25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4500-168071450001100 TABLET in 1 BOTTLE (68071-4500-1) 100 tablet2018-07-190000-00-00NoNoCurrent