Naftin

Product NDC
54766-772
11-digit product format
547660772
Labeler code
54766
Product ID
54766-772_43150f38-df38-5e12-e063-6294a90a1128
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naftifine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Sebela Pharmaceuticals Inc.
Application
NDA204286
Marketing category
NDA
Marketing start
2018-03-01
Marketing end
2026-10-31
Substance
NAFTIFINE HYDROCHLORIDE
Active strength
2 g/100g
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naftin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAFTIFINE HYDROCHLORIDE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii25UR9N9041
Rxcui1433734, 1433736

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
54766-772-45Naftin45 g in 1 TUBEGEL457
54766-772-45Naftin1 in 1 CARTONGEL17
54766-772-60Naftin60 g in 1 TUBEGEL607
54766-772-60Naftin1 in 1 CARTONGEL17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54766-772-45GM - Gram54766-77252a870e5-8fe1-4f19-a67b-61b3612cbb7d12018-03-08
54766-772-60GM - Gram54766-772690d4f34-9597-49e4-a125-5c8cf13aa2d912018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54766-772NAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [SEBELA PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 4 package rows20231213_6645994a-ecb3-277b-e053-2a91aa0a81e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1433734naftifine HCl 2 % Topical GelPSN6645994a-ecb3-277b-e053-2a91aa0a81e57
1433736NAFTIN 2 % Topical GelPSN6645994a-ecb3-277b-e053-2a91aa0a81e57
1433736naftifine hydrochloride 0.02 MG/MG Topical Gel [Naftin]SBD6645994a-ecb3-277b-e053-2a91aa0a81e57
1433734naftifine hydrochloride 0.02 MG/MG Topical GelSCD6645994a-ecb3-277b-e053-2a91aa0a81e57
1433734naftifine hydrochloride 2 % Topical GelSY6645994a-ecb3-277b-e053-2a91aa0a81e57
1433736Naftin 0.02 MG/MG Topical GelSY6645994a-ecb3-277b-e053-2a91aa0a81e57
1433736Naftin 2 % Topical GelSY6645994a-ecb3-277b-e053-2a91aa0a81e57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54766-772-45547660772451 TUBE in 1 CARTON (54766-772-45) / 45 g in 1 TUBE1 tube2018-03-012026-10-31NoNoCurrent
54766-772-60547660772601 TUBE in 1 CARTON (54766-772-60) / 60 g in 1 TUBE1 tube2018-03-012026-10-31NoNoCurrent