KOMBIGLYZE XR

Basic Information

Product Name

KOMBIGLYZE XR

FDA Product Code

0310-6125

Regulatory Information

NDC Product Code

0310-6125

Application Number

NDA200678

Marketing Category

C73594

Effective Date

October 24, 2019

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

metformin hydrochloride

Quantity: 1000 mg in 1 1

Code: 786Z46389E

Class Code: ACTIB

magnesium stearate

Code: 70097M6I30

Class Code: IACT

hypromellose 2208 (15000 mpa.s)

Code: Z78RG6M2N2

Class Code: IACT

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

Code: K679OBS311

Class Code: IACT

saxagliptin hydrochloride

Quantity: 2.5 mg in 1 1

Code: Z8J84YIX6L

Class Code: ACTIM

Active Moieties

metformin

Code: 9100L32L2N

saxagliptin anhydrous

Code: 8I7IO46IVQ

Basic Information

Regulatory Information

Company Information

Active Ingredients

magnesium stearate

hypromellose 2208 (15000 mpa.s)

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

Active Moieties

metformin

saxagliptin anhydrous