NDC 0591-3197

TERCONAZOLE

Terconazole

TERCONAZOLE is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc. The primary component is Terconazole.

Product ID0591-3197_6f162fe6-6443-11e8-9489-6877e1fc7600
NDC0591-3197
Product TypeHuman Prescription Drug
Proprietary NameTERCONAZOLE
Generic NameTerconazole
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2004-04-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA019964
Labeler NameActavis Pharma, Inc
Substance NameTERCONAZOLE
Active Ingredient Strength8 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0591-3197-52

1 TUBE, WITH APPLICATOR in 1 CARTON (0591-3197-52) > 20 g in 1 TUBE, WITH APPLICATOR
Marketing Start Date2004-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-3197-52 [00591319752]

TERCONAZOLE CREAM
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA019964
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2004-04-01
Marketing End Date2012-03-31

Drug Details

Active Ingredients

IngredientStrength
TERCONAZOLE8 mg/g

OpenFDA Data

SPL SET ID:dc32e601-561b-79fd-d46f-384a2d6e33a8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313227
  • 313226
  • UPC Code
  • 0305913197527
  • 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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