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
fb49b7d6-8071-44c7-a10c-e8116d7d5b42
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 24, 2017
Manufacturers
FDA
International Laboratories, LLC
DUNS: 023569924
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 Code54458-885
Application NumberNDA021073
Product Classification
M
Marketing Category
C73605
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2017
FDA Product Classification
INGREDIENTS (5)
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
Pioglitazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-883
Application NumberNDA021073
Product Classification
M
Marketing Category
C73605
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2017
FDA Product Classification
INGREDIENTS (5)
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 45 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Pioglitazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-884
Application NumberNDA021073
Product Classification
M
Marketing Category
C73605
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2017
FDA Product Classification
INGREDIENTS (5)
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT