NDC 0378-7625

Econazole Nitrate

Econazole Nitrate

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

Product ID0378-7625_5595e47f-ee4e-47e7-8169-359ea9d706dc
NDC0378-7625
Product TypeHuman Prescription Drug
Proprietary NameEconazole Nitrate
Generic NameEconazole Nitrate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-10-02
Marketing End Date2020-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA210364
Labeler NameMylan Pharmaceuticals Inc.
Substance NameECONAZOLE NITRATE
Active Ingredient Strength10 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN

Packaging

NDC 0378-7625-85

1 TUBE in 1 CARTON (0378-7625-85) > 85 g in 1 TUBE
Marketing Start Date2018-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-7625-85 [00378762585]

Econazole Nitrate CREAM
Marketing CategoryANDA
Application NumberANDA210364
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-10-02
Marketing End Date2020-01-31

NDC 0378-7625-49 [00378762549]

Econazole Nitrate CREAM
Marketing CategoryANDA
Application NumberANDA210364
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-10-02
Marketing End Date2020-01-31

NDC 0378-7625-15 [00378762515]

Econazole Nitrate CREAM
Marketing CategoryANDA
Application NumberANDA210364
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-10-02
Marketing End Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ECONAZOLE NITRATE10 mg/g

OpenFDA Data

SPL SET ID:150b8981-cd23-4f08-adf1-8987c38cc048
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

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