PIOGLITAZONEHYDROCHLORIDE
These highlights do not include all the information needed to use pioglitazone hydrochloride safely and effectively. See full prescribing information for pioglitazone hydrochloride. Pioglitazone Tablets, USP for oral use Initial U.S. Approval: 1999
Approved
Approval ID
f428d7d7-dbb1-4112-a651-5e0df7227cb8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2021
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PIOGLITAZONEHYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code63187-746
Application NumberANDA091298
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 1, 2021
Generic NamePIOGLITAZONEHYDROCHLORIDE
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT