NDC 0168-0347

Terconazole Vaginal Cream 0.8%

Terconazole

Terconazole Vaginal Cream 0.8% is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Terconazole.

Product ID0168-0347_65cb53ae-7417-48e5-9bb6-ca401ac73831
NDC0168-0347
Product TypeHuman Prescription Drug
Proprietary NameTerconazole Vaginal Cream 0.8%
Generic NameTerconazole
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2005-02-01
Marketing CategoryNDA / NDA
Application NumberNDA021735
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NameTERCONAZOLE
Active Ingredient Strength8 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0168-0347-20

20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20)
Marketing Start Date2020-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0347-20 [00168034720]

Terconazole Vaginal Cream 0.8% CREAM
Marketing CategoryNDA
Application NumberNDA021735
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-10-01
Marketing End Date2013-02-28

Drug Details

NDC Crossover Matching brand name "Terconazole Vaginal Cream 0.8%" or generic name "Terconazole"

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