NDC 21695-844

Terconazole

Terconazole

Terconazole is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Terconazole.

Product ID21695-844_5527cd23-567b-4019-8e5c-f71ee7ed2689
NDC21695-844
Product TypeHuman Prescription Drug
Proprietary NameTerconazole
Generic NameTerconazole
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2005-01-19
Marketing CategoryANDA / ANDA
Application NumberANDA076043
Labeler NameRebel Distributors Corp
Substance NameTERCONAZOLE
Active Ingredient Strength4 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-844-45

1 TUBE in 1 CARTON (21695-844-45) > 45 g in 1 TUBE
Marketing Start Date2005-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-844-45 [21695084445]

Terconazole CREAM
Marketing CategoryANDA
Application NumberANDA076043
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2005-01-19
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
TERCONAZOLE4 mg/g

OpenFDA Data

SPL SET ID:5527cd23-567b-4019-8e5c-f71ee7ed2689
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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