Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
A-S Medication Solutions
A-S Medication Solutions
830016429
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefprozil
Product Details
NDC Product Code
50090-1739Application Number
ANDA065340Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 24, 2019MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CefprozilActive
Code: 4W0459ZA4VClass: ACTIMQuantity: 500 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT