Terconazole
Terconazole Vaginal Cream 0.8%
Approved
Approval ID
1e32bf0d-2a93-44ac-ae28-8d34e10380c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terconazole
PRODUCT DETAILS
NDC Product Code50090-1196
Application NumberANDA075953
Marketing CategoryC73584
Route of AdministrationVAGINAL
Effective DateNovember 7, 2019
Generic NameTerconazole
INGREDIENTS (9)
TERCONAZOLEActive
Quantity: 8 mg in 1 g
Code: 0KJ2VE664U
Classification: ACTIB
butylated hydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT