Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Macleods Pharmaceuticals Limited
Macleods Pharmaceuticals Limited
676369519
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pioglitazole and metformin hydrochloride
Product Details
NDC Product Code
33342-177Application Number
ANDA204802Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 18, 2022PioglitazoneActive
Code: JQT35NPK6CClass: ACTIMQuantity: 15 mg in 1 1
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 850 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Pioglitazole and metformin hydrochloride
Product Details
NDC Product Code
33342-176Application Number
ANDA204802Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 18, 2022PioglitazoneActive
Code: JQT35NPK6CClass: ACTIMQuantity: 15 mg in 1 1
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT