NDC 68788-9848

Econazole Nitrate

Econazole Nitrate

Econazole Nitrate is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Econazole Nitrate.

Product ID68788-9848_ab4b1c84-0ad7-4d81-a566-be55758d14c1
NDC68788-9848
Product TypeHuman Prescription Drug
Proprietary NameEconazole Nitrate
Generic NameEconazole Nitrate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2012-03-29
Marketing CategoryANDA / ANDA
Application NumberANDA076005
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NameECONAZOLE NITRATE
Active Ingredient Strength10 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68788-9848-3

30 g in 1 TUBE (68788-9848-3)
Marketing Start Date2012-03-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9848-3 [68788984803]

Econazole Nitrate CREAM
Marketing CategoryANDA
Application NumberANDA076005
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-29
Marketing End Date2019-09-05

Drug Details

Active Ingredients

IngredientStrength
ECONAZOLE NITRATE10 mg/g

OpenFDA Data

SPL SET ID:bda93c0e-e18a-4c6e-8dcc-6bd6c9d06634
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857366
  • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]

    NDC Crossover Matching brand name "Econazole Nitrate" or generic name "Econazole Nitrate"

    NDCBrand NameGeneric Name
    0168-0312Econazole Nitrateeconazole nitrate
    0378-7625Econazole NitrateEconazole Nitrate
    21695-892Econazole NitrateEconazole Nitrate
    33261-956Econazole NitrateEconazole Nitrate
    45802-466Econazole NitrateEconazole Nitrate
    51672-1303Econazole NitrateEconazole Nitrate
    52565-022Econazole NitrateEconazole Nitrate
    63629-8645Econazole NitrateEconazole Nitrate
    63629-8646Econazole NitrateEconazole Nitrate
    63629-8647Econazole NitrateEconazole Nitrate
    63739-085Econazole NitrateEconazole Nitrate
    68788-7346Econazole NitrateEconazole Nitrate
    68788-7406Econazole NitrateEconazole Nitrate
    68788-8170Econazole NitrateEconazole Nitrate
    68788-8174Econazole NitrateEconazole Nitrate
    68788-9848Econazole NitrateEconazole Nitrate
    70512-029Econazole NitrateEconazole Nitrate
    72275-735EconavixEconazole Nitrate
    23710-100ECOZAeconazole nitrate
    72657-200ECOZAeconazole nitrate
    59088-752ZolpakEconazole Nitrate

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.