NDC 70518-1185

Terconazole

Terconazole

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

Product ID70518-1185_6cbe3c0b-b3f1-1b3e-e053-2a91aa0a2e25
NDC70518-1185
Product TypeHuman Prescription Drug
Proprietary NameTerconazole
Generic NameTerconazole
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2018-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA075953
Labeler NameREMEDYREPACK INC.
Substance NameTERCONAZOLE
Active Ingredient Strength8 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1185-0

1 TUBE, WITH APPLICATOR in 1 CARTON (70518-1185-0) > 20 g in 1 TUBE, WITH APPLICATOR
Marketing Start Date2018-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1185-0 [70518118500]

Terconazole CREAM
Marketing CategoryANDA
Application NumberANDA075953
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-14
Marketing End Date2020-05-19

Drug Details

Active Ingredients

IngredientStrength
TERCONAZOLE8 mg/g

OpenFDA Data

SPL SET ID:af444dd2-1624-4eeb-b959-7036c2337e3a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313227
  • 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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