Pioglitazone
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
482cef76-0623-4b4f-a0ea-f008c97b2281
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2022
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pioglitazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-056
Application NumberANDA202467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2022
FDA Product Classification
INGREDIENTS (5)
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 45 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Pioglitazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-054
Application NumberANDA202467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2022
FDA Product Classification
INGREDIENTS (5)
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Pioglitazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-055
Application NumberANDA202467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2022
FDA Product Classification
INGREDIENTS (5)
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT