NDC 52959-811

TERCONAZOLE

Terconazole

TERCONAZOLE is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Terconazole.

Product ID52959-811_efdfe922-d360-43bc-b65c-245178658b4a
NDC52959-811
Product TypeHuman Prescription Drug
Proprietary NameTERCONAZOLE
Generic NameTerconazole
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2004-04-01
Marketing CategoryNDA / NDA
Application NumberNDA019579
Labeler NameH.J. Harkins Company, Inc.
Substance NameTERCONAZOLE
Active Ingredient Strength4 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52959-811-03

45 g in 1 TUBE, WITH APPLICATOR (52959-811-03)
Marketing Start Date2004-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-811-03 [52959081103]

TERCONAZOLE CREAM
Marketing CategoryNDA
Application NumberNDA019579
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2004-04-01
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
TERCONAZOLE4 mg/g

OpenFDA Data

SPL SET ID:426c71b4-39cf-4d12-ad6a-8f64a7c15490
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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