NDC 0713-0552

Terconazole

Terconazole

Terconazole is a Vaginal Suppository in the Human Prescription Drug category. It is labeled and distributed by Cosette Pharmaceuticals, Inc.. The primary component is Terconazole.

Product ID0713-0552_0e4ec1e5-5b43-4410-9a11-c708e1df1103
NDC0713-0552
Product TypeHuman Prescription Drug
Proprietary NameTerconazole
Generic NameTerconazole
Dosage FormSuppository
Route of AdministrationVAGINAL
Marketing Start Date2015-09-25
Marketing CategoryANDA / ANDA
Application NumberANDA077553
Labeler NameCosette Pharmaceuticals, Inc.
Substance NameTERCONAZOLE
Active Ingredient Strength80 mg/1
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0713-0552-73

3 BLISTER PACK in 1 CARTON (0713-0552-73) > 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date2015-09-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0713-0552-73 [00713055273]

Terconazole SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA077553
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-25

Drug Details

Active Ingredients

IngredientStrength
TERCONAZOLE80 mg/1

OpenFDA Data

SPL SET ID:38cd1718-6b3c-415d-a17f-7b399adb0ba2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198245

    • 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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