FDA.reportPublic FDA data

Naftifine Hydrochloride

Product NDC
51672-1376
11-digit product format
516721376
Labeler code
51672
Product ID
51672-1376_4aa35016-7749-87c7-e063-6394a90ac5c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naftifine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA208201
Marketing category
ANDA
Marketing start
2023-04-01
Substance
NAFTIFINE HYDROCHLORIDE
Active strength
20 mg/g
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naftifine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAFTIFINE HYDROCHLORIDE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii25UR9N9041
Rxcui1433734

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f630d5a-8a28-4ac5-8ede-8b54b7617055Product name320210512
6aca302d-6492-4ac9-8829-e023cb64c91cProduct name120190627
ba2e3195-29b1-b94a-4345-149632e97b51Product name320161117
7ac69d99-c06d-0e83-7872-6229bc9878f9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1376-3Naftifine Hydrochloride60 g in 1 TUBEGEL6011
51672-1376-3Naftifine Hydrochloride1 in 1 CARTONGEL111
51672-1376-6Naftifine Hydrochloride45 g in 1 TUBEGEL4511
51672-1376-6Naftifine Hydrochloride1 in 1 CARTONGEL111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1376-3GM - Gram51672-1376990ad577-e302-4cd8-ad3d-22e267b5f5e012023-05-05
51672-1376-6GM - Gram51672-1376a784de9c-7f21-4328-954b-b7dfb30fd9d412023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1376NAFTIFINE HYDROCHLORIDE GEL [TARO PHARMACEUTICALS U.S.A., INC.]9Current NDC, Legacy NDC, 4 package rows20230401_92d3ec30-2176-49cd-8a70-668ef65e7663.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1433734naftifine HCl 2 % Topical GelPSN92d3ec30-2176-49cd-8a70-668ef65e766311
1433734naftifine hydrochloride 0.02 MG/MG Topical GelSCD92d3ec30-2176-49cd-8a70-668ef65e766311
1433734naftifine hydrochloride 2 % Topical GelSY92d3ec30-2176-49cd-8a70-668ef65e766311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1376-3516721376031 TUBE in 1 CARTON (51672-1376-3) / 60 g in 1 TUBE1 tube2023-04-010000-00-00NoNoCurrent
51672-1376-6516721376061 TUBE in 1 CARTON (51672-1376-6) / 45 g in 1 TUBE1 tube2023-04-010000-00-00NoNoCurrent