Pioglitazone and metformin
These highlights do not include all the information needed to use PIOGLITAZONE and METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE and METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE and METFORMIN HYDROCHLORIDE, tablets for oral useInitial U.S. Approval: 2005
Approved
Approval ID
171a41f7-da5a-4a55-bd0e-40a29977b2e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 18, 2018
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pioglitazone and metformin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-5626
Application NumberANDA091273
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone and metformin
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2018
FDA Product Classification
INGREDIENTS (11)
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Pioglitazone and metformin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-5627
Application NumberANDA091273
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone and metformin
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2018
FDA Product Classification
INGREDIENTS (11)
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 850 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT