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
29145eca-d3de-475d-9171-3803966d6ba7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 23, 2016
Manufacturers
FDA
Cambridge Therapeutics Technologies, LLC
DUNS: 080072003
Products 1
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 Code70882-105
Application NumberANDA091273
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone and metformin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2016
FDA Product Classification
INGREDIENTS (11)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT