Terconazole

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

A-S Medication Solutions

DUNS Number

830016429

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

50090-6266

Application Number

ANDA076712

Marketing Category

ANDA (C73584)

Route of Administration

VAGINAL

Effective Date

March 9, 2021

Ingredients

Code: 0KJ2VE664UClass: ACTIBQuantity: 4 mg in 1 g

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CETYL ALCOHOLInactive

Code: 936JST6JCNClass: IACT

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJSClass: IACT

POLYSORBATE 60Inactive

Code: CAL22UVI4MClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

STEARYL ALCOHOLInactive

Code: 2KR89I4H1YClass: IACT