FDA.reportPublic FDA data

Terbinafine Hydrochloride

Product NDC
51672-2140
11-digit product format
516722140
Labeler code
51672
Product ID
51672-2140_38e5619e-f821-ac84-e063-6394a90a8153
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077511
Marketing category
ANDA
Marketing start
2007-07-02
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
1 g/100g
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 HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G
Rxcui992528

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
51672-2140-12024-08-20C16284748780-11030e365-2f41-111a-e063-dadaa90a10e2Terbinafine Hydrochloride
51672-2140-12024-01-30C16284748780-11030e365-2f41-111a-e063-dadaa90a10e2Terbinafine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2140-1Terbinafine Hydrochloride1 in 1 CARTONCREAM14
51672-2140-1Terbinafine Hydrochloride15 g in 1 TUBECREAM154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2140TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 2 package rows20240821_ca9cd2bd-4805-4469-b754-01a7487b71a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSNca9cd2bd-4805-4469-b754-01a7487b71a64
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCDca9cd2bd-4805-4469-b754-01a7487b71a64
992528terbinafine hydrochloride 1 % Topical CreamSYca9cd2bd-4805-4469-b754-01a7487b71a64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2140-1516722140011 TUBE in 1 CARTON (51672-2140-1) / 15 g in 1 TUBE1 tube2019-02-280000-00-00NoNoCurrent