Actoplus Met
These highlights do not include all the information needed to use ACTOPLUS MET safely and effectively. See full prescribing information for ACTOPLUS MET. ACTOPLUS MET (pioglitazone and metformin hydrochloride) tablets, for oral useInitial U.S. Approval: 2005
Approved
Approval ID
42e49120-6f3f-11db-9fe1-0800200c9a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pioglitazone and metformin hydrochloride
PRODUCT DETAILS
NDC Product Code64764-158
Application NumberNDA021842
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 5, 2023
Generic Namepioglitazone and metformin hydrochloride
INGREDIENTS (10)
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
metformin hydrochlorideActive
Quantity: 850 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
hypromellose 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
polyethylene glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT