Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metformin Hydrochloride
Product Details
NDC Product Code
0378-6001Application Number
ANDA200690Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 25, 2017LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Metformin Hydrochloride
Product Details
NDC Product Code
0378-6002Application Number
ANDA200690Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 25, 2017AMMONIAInactive
Code: 5138Q19F1XClass: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT