"0378-1575-05" National Drug Code (NDC)

Pioglitazone Hydrochloride And Metformin Hydrochloride 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1575-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-1575-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1575-05)
Product NDC0378-1575
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePioglitazone Hydrochloride And Metformin Hydrochloride
Non-Proprietary NamePioglitazone Hydrochloride And Metformin Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20120817
Marketing Category NameANDA
Application NumberANDA090406
ManufacturerMylan Pharmaceuticals Inc.
Substance NameMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Strength850; 15
Strength Unitmg/1; mg/1
Pharmacy ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient]

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