pioglitazone
PIOGLITAZONE TABLETS
Approved
Approval ID
008c5659-7430-4a9b-927f-5cb97763616a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1022
Application NumberANDA202456
Product Classification
M
Marketing Category
C73584
G
Generic Name
pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2023
FDA Product Classification
INGREDIENTS (5)
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
pioglitazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1021
Application NumberANDA202456
Product Classification
M
Marketing Category
C73584
G
Generic Name
pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2023
FDA Product Classification
INGREDIENTS (5)
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
pioglitazone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1023
Application NumberANDA202456
Product Classification
M
Marketing Category
C73584
G
Generic Name
pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2023
FDA Product Classification
INGREDIENTS (5)
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 45 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT