kombiglyze xr

Generic: saxagliptin and metformin hydrochloride

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kombiglyze xr
Generic Name saxagliptin and metformin hydrochloride
Labeler astrazeneca pharmaceuticals lp
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1, saxagliptin hydrochloride 2.5 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-6125
Product ID 0310-6125_6c42f9cf-c369-41d5-9d7b-4b09fe27b8fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200678
Marketing Start 2014-12-04
Marketing End 2026-03-31

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs] dipeptidyl peptidase 4 inhibitor [epc] dipeptidyl peptidase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03106125
Hyphenated Format 0310-6125

Supplemental Identifiers

RxCUI
1043563 1043567 1043570 1043574 1043578 1043582
UNII
Z8J84YIX6L 786Z46389E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kombiglyze xr (source: ndc)
Generic Name saxagliptin and metformin hydrochloride (source: ndc)
Application Number NDA200678 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6125-60)
source: ndc

Packages (1)

0310-6125-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6125-60)

Ingredients (2)

metformin hydrochloride (1000 mg/1) saxagliptin hydrochloride (2.5 mg/1)

Linked Drug Pages (1)

KOMBIGLYZE XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6c42f9cf-c369-41d5-9d7b-4b09fe27b8fb", "openfda": {"unii": ["Z8J84YIX6L", "786Z46389E"], "rxcui": ["1043563", "1043567", "1043570", "1043574", "1043578", "1043582"], "spl_set_id": ["fbd25da4-ebe6-45c9-beb8-93523d11a0b4"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6125-60)", "package_ndc": "0310-6125-60", "marketing_end_date": "20260331", "marketing_start_date": "20141204"}], "brand_name": "KOMBIGLYZE XR", "product_id": "0310-6125_6c42f9cf-c369-41d5-9d7b-4b09fe27b8fb", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "0310-6125", "generic_name": "SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KOMBIGLYZE", "brand_name_suffix": "XR", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}, {"name": "SAXAGLIPTIN HYDROCHLORIDE", "strength": "2.5 mg/1"}], "application_number": "NDA200678", "marketing_category": "NDA", "marketing_end_date": "20260331", "marketing_start_date": "20141204"}