NDC 50090-0917

Terconazole

Terconazole

Terconazole is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Terconazole.

Product ID50090-0917_2e7ebe5a-347c-44d4-bdb9-273bd71c2a16
NDC50090-0917
Product TypeHuman Prescription Drug
Proprietary NameTerconazole
Generic NameTerconazole
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2005-01-19
Marketing CategoryANDA / ANDA
Application NumberANDA076043
Labeler NameA-S Medication Solutions
Substance NameTERCONAZOLE
Active Ingredient Strength4 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50090-0917-0

1 TUBE, WITH APPLICATOR in 1 CARTON (50090-0917-0) > 45 g in 1 TUBE, WITH APPLICATOR
Marketing Start Date2014-11-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-0917-0 [50090091700]

Terconazole CREAM
Marketing CategoryANDA
Application NumberANDA076043
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2014-11-28

Drug Details

Active Ingredients

IngredientStrength
TERCONAZOLE4 mg/g

OpenFDA Data

SPL SET ID:b922feb5-cd85-4f13-9a18-913e58f8da83
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.