"54868-5553-0" National Drug Code (NDC)

NDC Code	54868-5553-0
Package Description	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-5553-0)
Product NDC	54868-5553
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Actoplus Met
Non-Proprietary Name	Pioglitazone Hydrochloride And Metformin Hydrochloride
Dosage Form	TABLET, FILM COATED
Usage	ORAL
Start Marketing Date	20060321
Marketing Category Name	NDA
Application Number	NDA021842
Manufacturer	Physicians Total Care, Inc.
Substance Name	PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE
Strength	15; 850
Strength Unit	mg/1; mg/1
Pharmacy Classes	Peroxisome 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]