Terconazole

Manufacturing Establishments1

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

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

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

NDC Product Code

54868-5183

Application Number

ANDA075953

Marketing Category

ANDA (C73584)

Route of Administration

VAGINAL

Effective Date

August 30, 2010

Ingredients

Code: 0KJ2VE664UClass: ACTIBQuantity: 8 mg in 1 g

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJSClass: IACT

POLYSORBATE 60Inactive

Code: CAL22UVI4MClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CETYL ALCOHOLInactive

Code: 936JST6JCNClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

STEARYL ALCOHOLInactive

Code: 2KR89I4H1YClass: IACT