NDC 50458-535

Terazol 7

Terconazole

Terazol 7 is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Terconazole.

Product ID50458-535_9a055cd8-638b-11ea-a644-412efc2ca371
NDC50458-535
Product TypeHuman Prescription Drug
Proprietary NameTerazol 7
Generic NameTerconazole
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date1987-12-31
Marketing End Date2020-06-15
Marketing CategoryNDA / NDA
Application NumberNDA019579
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameTERCONAZOLE
Active Ingredient Strength4 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN

Packaging

NDC SPL Data Element Entries

NDC 50458-535-01 [50458053501]

Terazol 7 CREAM
Marketing CategoryNDA
Application NumberNDA019579
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1987-12-31
Marketing End Date2018-06-30

Drug Details

Active Ingredients

IngredientStrength
TERCONAZOLE4 mg/g

OpenFDA Data

SPL SET ID:6f2626b3-6053-4f7a-bc5d-78e30d983f90
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313227
  • 313226
  • 198245
  • 209285
  • 209284
  • 209283
  • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]
    • Azole Antifungal [EPC]
    • Azoles [CS]

    NDC Crossover Matching brand name "Terazol 7" or generic name "Terconazole"

    NDCBrand NameGeneric Name
    50458-535Terazol 7TERCONAZOLE
    50458-531Terazol 3TERCONAZOLE
    50458-536Terazol 3TERCONAZOLE
    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

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