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Pioglitazone Hydrochloride and Metformin Hydrochloride

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 use Initial U.S. Approval: 2005

Approved
Approval ID

8d252dab-e868-42d3-95ea-69423d909e84

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 27, 2022

Manufacturers
FDA

Rising Health, LLC

DUNS: 080500961

FDA

Rising Pharma Holdings, Inc.

DUNS: 116880195

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pioglitazone Hydrochloride and Metformin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57237-217
Application NumberANDA200823
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone Hydrochloride and Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2022
FDA Product Classification

INGREDIENTS (10)

PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Pioglitazone Hydrochloride and Metformin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57237-218
Application NumberANDA200823
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone Hydrochloride and Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2022
FDA Product Classification

INGREDIENTS (10)

PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 850 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT

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Pioglitazone Hydrochloride and Metformin Hydrochloride - FDA Drug Approval Details