NDC 54766-770

Naftin

Naftifine Hydrochloride

Naftin is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is Naftifine Hydrochloride.

Product ID54766-770_7d8a5d94-b15d-89f8-e053-2a91aa0a104b
NDC54766-770
Product TypeHuman Prescription Drug
Proprietary NameNaftin
Generic NameNaftifine Hydrochloride
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2018-01-22
Marketing CategoryNDA / NDA
Application NumberNDA019356
Labeler NameSebela Pharmaceuticals Inc.
Substance NameNAFTIFINE HYDROCHLORIDE
Active Ingredient Strength10 mg/g
Pharm ClassesAllylamine [CS],Allylamine Antifungal [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54766-770-40

1 TUBE in 1 CARTON (54766-770-40) > 40 g in 1 TUBE
Marketing Start Date2018-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54766-770-40 [54766077040]

Naftin GEL
Marketing CategoryNDA
Application NumberNDA019356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-01-22

NDC 54766-770-60 [54766077060]

Naftin GEL
Marketing CategoryNDA
Application NumberNDA019356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-01-22

NDC 54766-770-90 [54766077090]

Naftin GEL
Marketing CategoryNDA
Application NumberNDA019356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-01-22

Drug Details

Active Ingredients

IngredientStrength
NAFTIFINE HYDROCHLORIDE10 mg/g

OpenFDA Data

SPL SET ID:6371fceb-b98e-86a5-e053-2a91aa0a3d9e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 896108
  • 896106
    • UPC Code
  • 0354766770401

    • Pharmacological Class

    • Allylamine [CS]
    • Allylamine Antifungal [EPC]
    • Allylamine [CS]
    • Allylamine Antifungal [EPC]

    Medicade Reported Pricing

    54766077090 NAFTIN 1% GEL

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "Naftin" or generic name "Naftifine Hydrochloride"

    NDCBrand NameGeneric Name
    0259-4126NaftinNAFTIFINE HYDROCHLORIDE
    54766-102NaftinNaftifine Hydrochloride
    54766-770NaftinNAFTIFINE HYDROCHLORIDE
    54766-772NaftinNaftifine Hydrochloride
    0115-1510NAFTIFINE HYDROCHLORIDENAFTIFINE HYDROCHLORIDE
    0115-1512NAFTIFINE HYDROCHLORIDENAFTIFINE HYDROCHLORIDE
    40085-201Naftifine HydrochlorideNAFTIFINE HYDROCHLORIDE
    40085-203Naftifine HydrochlorideNAFTIFINE HYDROCHLORIDE
    51672-1362Naftifine HydrochlorideNaftifine Hydrochloride
    51672-1368Naftifine HydrochlorideNaftifine Hydrochloride
    51672-1376Naftifine HydrochlorideNaftifine Hydrochloride
    70700-161Naftifine hydrochlorideNaftifine hydrochloride

    Trademark Results [Naftin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NAFTIN
    NAFTIN
    73706755 not registered Dead/Abandoned
    THAMES PHARMACAL CO., INC.
    1988-01-21
    NAFTIN
    NAFTIN
    73589735 1412990 Live/Registered
    ALLERGAN PHARMACEUTICALS, INC.
    1986-03-24
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