PIOGLITAZONE HYDROCHLORIDE
These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS. PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999
Approved
Approval ID
08dc565a-32c8-4009-a37a-922a6a290142
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2021
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pioglitazone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71610-497
Application NumberANDA200268
Product Classification
M
Marketing Category
C73584
G
Generic Name
pioglitazone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2021
FDA Product Classification
INGREDIENTS (5)
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT