Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aurobindo Pharma Limited
Aurobindo Pharma Limited
918917639
Products2
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
65862-068Application Number
ANDA065340Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 23, 2021CefprozilActive
Code: 4W0459ZA4VClass: ACTIMQuantity: 250 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
Cefprozil
Product Details
NDC Product Code
65862-069Application Number
ANDA065340Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 23, 2021CefprozilActive
Code: 4W0459ZA4VClass: ACTIMQuantity: 500 mg in 1 1
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT