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
2f23c56c-2b13-4332-b945-96726deffbfe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 9, 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 Code54458-864
Application NumberANDA077210
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2017
FDA Product Classification
INGREDIENTS (5)
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 45 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
Pioglitazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-866
Application NumberANDA077210
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2017
FDA Product Classification
INGREDIENTS (5)
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Pioglitazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-865
Application NumberANDA077210
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2017
FDA Product Classification
INGREDIENTS (5)
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT