janumet xr

Generic: sitagliptin and metformin hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name janumet xr
Generic Name sitagliptin and metformin hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1, sitagliptin phosphate 50 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5504
Product ID 50090-5504_daeedefc-b17c-4c81-8677-dc75b1eb8af2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202270
Listing Expiration 2026-12-31
Marketing Start 2012-02-02

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 500905504
Hyphenated Format 50090-5504

Supplemental Identifiers

RxCUI
1243843 2709477
UNII
786Z46389E TS63EW8X6F

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 janumet xr (source: ndc)
Generic Name sitagliptin and metformin hydrochloride (source: ndc)
Application Number NDA202270 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-0)
  • 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-1)
source: ndc

Packages (2)

50090-5504-0 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-0) 50090-5504-1 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-1)

Ingredients (2)

metformin hydrochloride (1000 mg/1) sitagliptin phosphate (50 mg/1)

Linked Drug Pages (1)

JANUMET XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "daeedefc-b17c-4c81-8677-dc75b1eb8af2", "openfda": {"unii": ["786Z46389E", "TS63EW8X6F"], "rxcui": ["1243843", "2709477"], "spl_set_id": ["90c0244b-afb3-4e69-b79f-486d002ca432"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-0)", "package_ndc": "50090-5504-0", "marketing_start_date": "20210331"}, {"sample": false, "description": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-1)", "package_ndc": "50090-5504-1", "marketing_start_date": "20210901"}], "brand_name": "JANUMET XR", "product_id": "50090-5504_daeedefc-b17c-4c81-8677-dc75b1eb8af2", "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": "50090-5504", "generic_name": "sitagliptin and metformin hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "JANUMET", "brand_name_suffix": "XR", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}, {"name": "SITAGLIPTIN PHOSPHATE", "strength": "50 mg/1"}], "application_number": "NDA202270", "marketing_category": "NDA", "marketing_start_date": "20120202", "listing_expiration_date": "20261231"}