Saxagliptin and Metformin Hydrochloride

These highlights do not include all the information needed to use SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. SAXAGLIPTIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2010

Approved

Approval ID

65884427-4dde-63bb-a23f-36a7779c0a6b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 28, 2023

Manufacturers

FDA

Dr.Reddys Laboratories Inc

DUNS: 802315887

Products 3

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

Saxagliptin and Metformin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43598-619

Application NumberANDA207678

Product Classification

Marketing Category

C73584

Generic Name

Saxagliptin and Metformin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJuly 28, 2023

FDA Product Classification

INGREDIENTS (20)

SAXAGLIPTINActive

Quantity: 5 mg in 1 1

Code: 9GB927LAJW

Classification: ACTIM

METFORMIN HYDROCHLORIDEActive

Quantity: 1000 mg in 1 1

Code: 786Z46389E

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

HYPROMELLOSE 2208 (100000 MPA.S)Inactive

Code: VM7F0B23ZI

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

POVIDONE K90Inactive

Code: RDH86HJV5Z

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

Saxagliptin and Metformin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43598-620

Application NumberANDA207678

Product Classification

Marketing Category

C73584

Generic Name

Saxagliptin and Metformin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJuly 28, 2023

FDA Product Classification

INGREDIENTS (21)

HYPROMELLOSE 2208 (100000 MPA.S)Inactive

Code: VM7F0B23ZI

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

SAXAGLIPTINActive

Quantity: 5 mg in 1 1

Code: 9GB927LAJW

Classification: ACTIM

METFORMIN HYDROCHLORIDEActive

Quantity: 500 mg in 1 1

Code: 786Z46389E

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95

Classification: IACT

POVIDONE K90Inactive

Code: RDH86HJV5Z

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Saxagliptin and Metformin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43598-618

Application NumberANDA207678

Product Classification

Marketing Category

C73584

Generic Name

Saxagliptin and Metformin Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJuly 28, 2023

FDA Product Classification

INGREDIENTS (20)

SAXAGLIPTINActive

Quantity: 2.5 mg in 1 1

Code: 9GB927LAJW

Classification: ACTIM

METFORMIN HYDROCHLORIDEActive

Quantity: 1000 mg in 1 1

Code: 786Z46389E

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

HYPROMELLOSE 2208 (100000 MPA.S)Inactive

Code: VM7F0B23ZI

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POVIDONE K90Inactive

Code: RDH86HJV5Z

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

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Saxagliptin and Metformin Hydrochloride

Products 3

Saxagliptin and Metformin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

Saxagliptin and Metformin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

Saxagliptin and Metformin Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

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