FDA.reportPublic FDA data

Naftifine Hydrochloride

Product NDC
51672-1362
11-digit product format
516721362
Labeler code
51672
Product ID
51672-1362_39620da3-e660-e94f-e063-6294a90afd69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naftifine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA205975
Marketing category
ANDA
Marketing start
2016-09-08
Substance
NAFTIFINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii25UR9N9041
Rxcui896110

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
51672-1362-1Naftifine Hydrochloride1 in 1 CARTONCREAM13
51672-1362-1Naftifine Hydrochloride15 g in 1 TUBECREAM153
51672-1362-2Naftifine Hydrochloride30 g in 1 TUBECREAM303
51672-1362-2Naftifine Hydrochloride1 in 1 CARTONCREAM13
51672-1362-3Naftifine Hydrochloride1 in 1 CARTONCREAM13
51672-1362-3Naftifine Hydrochloride60 g in 1 TUBECREAM603
51672-1362-8Naftifine Hydrochloride90 g in 1 TUBECREAM903
51672-1362-8Naftifine Hydrochloride1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1362-3GM - Gram51672-136236a9aab6-5a08-449f-9e00-1c6868eb25d512017-03-06
51672-1362-8GM - Gram51672-13629d8249c0-21a8-45d3-9e5b-b13785221f7012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1362NAFTIFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2Current NDC, Legacy NDC, 8 package rows20180621_d50961c2-e97f-4583-91d6-7cafd25a8c3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896110naftifine HCl 1 % Topical CreamPSNd50961c2-e97f-4583-91d6-7cafd25a8c3d3
896110naftifine hydrochloride 10 MG/ML Topical CreamSCDd50961c2-e97f-4583-91d6-7cafd25a8c3d3
896110naftifine hydrochloride 1 % Topical CreamSYd50961c2-e97f-4583-91d6-7cafd25a8c3d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1362-1516721362011 TUBE in 1 CARTON (51672-1362-1) / 15 g in 1 TUBE1 tube2016-09-080000-00-00NoNoCurrent
51672-1362-2516721362021 TUBE in 1 CARTON (51672-1362-2) / 30 g in 1 TUBE1 tube2016-09-080000-00-00NoNoCurrent
51672-1362-3516721362031 TUBE in 1 CARTON (51672-1362-3) / 60 g in 1 TUBE1 tube2016-09-080000-00-00NoNoCurrent
51672-1362-8516721362081 TUBE in 1 CARTON (51672-1362-8) / 90 g in 1 TUBE1 tube2016-09-080000-00-00NoNoCurrent