Cefprozil

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

50090-1188

Application Number

ANDA065208

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 9, 2018

Ingredients

Code: 4W0459ZA4VClass: ACTIMQuantity: 500 mg in 1 1

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT