FDA.reportPublic FDA data

Naftifine Hydrochloride

Product NDC
51672-1368
11-digit product format
516721368
Labeler code
51672
Product ID
51672-1368_438dc98f-5e1f-b739-e063-6294a90a87a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naftifine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA206901
Marketing category
ANDA
Marketing start
2016-01-06
Substance
NAFTIFINE HYDROCHLORIDE
Active strength
20 mg/g
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
Naftifine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAFTIFINE HYDROCHLORIDE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii25UR9N9041
Rxcui1246096

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
51672-1368-2Naftifine Hydrochloride30 g in 1 TUBECREAM307
51672-1368-2Naftifine Hydrochloride1 in 1 CARTONCREAM17
51672-1368-3Naftifine Hydrochloride1 in 1 CARTONCREAM17
51672-1368-3Naftifine Hydrochloride60 g in 1 TUBECREAM607
51672-1368-6Naftifine Hydrochloride45 g in 1 TUBECREAM457
51672-1368-6Naftifine Hydrochloride1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1368-3GM - Gram51672-1368e1306415-5931-49b7-8ff2-5952dea8c10e12016-03-04
51672-1368-6GM - Gram51672-13681993a079-6727-4677-9b1d-c32123497f9b12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1368NAFTIFINE HYDROCHLORIDE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 6 package rows20250529_a740fc0d-45b3-411f-9dfd-f3d637b8a95f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246096naftifine HCl 2 % Topical CreamPSNa740fc0d-45b3-411f-9dfd-f3d637b8a95f7
1246096naftifine hydrochloride 20 MG/ML Topical CreamSCDa740fc0d-45b3-411f-9dfd-f3d637b8a95f7
1246096naftifine hydrochloride 2 % Topical CreamSYa740fc0d-45b3-411f-9dfd-f3d637b8a95f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1368-2516721368021 TUBE in 1 CARTON (51672-1368-2) / 30 g in 1 TUBE1 tube2016-01-060000-00-00NoNoCurrent
51672-1368-3516721368031 TUBE in 1 CARTON (51672-1368-3) / 60 g in 1 TUBE1 tube2016-01-060000-00-00NoNoCurrent
51672-1368-6516721368061 TUBE in 1 CARTON (51672-1368-6) / 45 g in 1 TUBE1 tube2016-01-060000-00-00NoNoCurrent