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
692e662a-3b31-42c3-a075-42abe44c74db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2022
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
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 Code16714-645
Application NumberANDA202467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2022
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
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 Code16714-646
Application NumberANDA202467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2022
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
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 Code16714-647
Application NumberANDA202467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2022
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
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