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KOMBIGLYZE

These highlights do not include all the information needed to use KOMBIGLYZE XR safely and effectively. See full prescribing information for KOMBIGLYZE XR. KOMBIGLYZE XR (saxagliptin and metformin hydrochloride extended-release) tablets, for oral useInitial U.S. Approval: 2010

Approved
Approval ID

fbd25da4-ebe6-45c9-beb8-93523d11a0b4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 24, 2019

Manufacturers
FDA

AstraZeneca Pharmaceuticals LP

DUNS: 054743190

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 Code0310-6135
Application NumberNDA200678
Product Classification
M
Marketing Category
C73594
G
Generic Name
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2019
FDA Product Classification

INGREDIENTS (7)

hypromellose 2208 (15000 mpa.s)Inactive
Code: Z78RG6M2N2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
metformin hydrochlorideActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
saxagliptin hydrochlorideActive
Quantity: 5 mg in 1 1
Code: Z8J84YIX6L
Classification: ACTIM

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0310-6125
Application NumberNDA200678
Product Classification
M
Marketing Category
C73594
G
Generic Name
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2019
FDA Product Classification

INGREDIENTS (5)

metformin hydrochlorideActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hypromellose 2208 (15000 mpa.s)Inactive
Code: Z78RG6M2N2
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
saxagliptin hydrochlorideActive
Quantity: 2.5 mg in 1 1
Code: Z8J84YIX6L
Classification: ACTIM

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0310-6145
Application NumberNDA200678
Product Classification
M
Marketing Category
C73594
G
Generic Name
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2019
FDA Product Classification

INGREDIENTS (5)

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
metformin hydrochlorideActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
hypromellose 2208 (15000 mpa.s)Inactive
Code: Z78RG6M2N2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
saxagliptin hydrochlorideActive
Quantity: 5 mg in 1 1
Code: Z8J84YIX6L
Classification: ACTIM

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KOMBIGLYZE - FDA Drug Approval Details