NDC 0168-0346

Terconazole

Terconazole

Terconazole is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Terconazole.

Product ID0168-0346_16e72753-100e-4669-948e-0651291b6673
NDC0168-0346
Product TypeHuman Prescription Drug
Proprietary NameTerconazole
Generic NameTerconazole
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2005-02-18
Marketing CategoryANDA / ANDA
Application NumberANDA076712
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NameTERCONAZOLE
Active Ingredient Strength4 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0168-0346-46

45 g in 1 TUBE, WITH APPLICATOR (0168-0346-46)
Marketing Start Date2005-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0346-46 [00168034646]

Terconazole CREAM
Marketing CategoryANDA
Application NumberANDA076712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2005-02-18

Drug Details

Active Ingredients

IngredientStrength
TERCONAZOLE4 mg/g

OpenFDA Data

SPL SET ID:10e84353-93d2-461d-8b79-e9294df047ae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313226

    • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]

    NDC Crossover Matching brand name "Terconazole" or generic name "Terconazole"

    NDCBrand NameGeneric Name
    0168-0346Terconazoleterconazole
    0168-0347Terconazoleterconazole
    0591-3196TERCONAZOLETERCONAZOLE
    0591-3197TERCONAZOLETERCONAZOLE
    0713-0552TerconazoleTerconazole
    21695-844TerconazoleTerconazole
    21695-933TERCONAZOLEterconazole
    45802-717TerconazoleTerconazole
    50090-0917TerconazoleTerconazole
    50090-1196TerconazoleTerconazole
    50090-2341TERCONAZOLETERCONAZOLE
    50090-6266Terconazoleterconazole
    51672-1302TerconazoleTerconazole
    51672-1304TerconazoleTerconazole
    51672-1330TerconazoleTerconazole
    52959-811TERCONAZOLEterconazole
    53002-7240TerconazoleTerconazole
    53002-8130TerconazoleTerconazole
    55045-3259TERCONAZOLEterconazole
    63629-8837Terconazoleterconazole
    68071-1626TerconazoleTerconazole
    70518-1185TerconazoleTerconazole
    50458-531Terazol 3TERCONAZOLE
    50458-536Terazol 3TERCONAZOLE
    50458-535Terazol 7TERCONAZOLE
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