janumet xr

Generic: sitagliptin and metformin hydrochloride

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name janumet xr
Generic Name sitagliptin and metformin hydrochloride
Labeler merck sharp & dohme llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1, sitagliptin phosphate 50 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-0078
Product ID 0006-0078_4323fb1c-54a7-4648-bfe0-28fb4cb65f50
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 00060078
Hyphenated Format 0006-0078

Supplemental Identifiers

RxCUI
1243833 1243843 1243848 2709470 2709477 2709482
UNII
TS63EW8X6F 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 janumet xr (source: ndc)
Generic Name sitagliptin and metformin hydrochloride (source: ndc)
Application Number NDA202270 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 2 BOTTLE in 1 CARTON (0006-0078-28) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61)
  • 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-62)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-82)
source: ndc

Packages (4)

0006-0078-28 2 BOTTLE in 1 CARTON (0006-0078-28) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14) 0006-0078-61 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61) 0006-0078-62 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-62) 0006-0078-82 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-82)

Ingredients (2)

metformin hydrochloride (500 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": "4323fb1c-54a7-4648-bfe0-28fb4cb65f50", "openfda": {"unii": ["TS63EW8X6F", "786Z46389E"], "rxcui": ["1243833", "1243843", "1243848", "2709470", "2709477", "2709482"], "spl_set_id": ["64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "2 BOTTLE in 1 CARTON (0006-0078-28)  / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14)", "package_ndc": "0006-0078-28", "marketing_start_date": "20120202"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61)", "package_ndc": "0006-0078-61", "marketing_start_date": "20120202"}, {"sample": false, "description": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-62)", "package_ndc": "0006-0078-62", "marketing_start_date": "20120202"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-82)", "package_ndc": "0006-0078-82", "marketing_start_date": "20120202"}], "brand_name": "JANUMET XR", "product_id": "0006-0078_4323fb1c-54a7-4648-bfe0-28fb4cb65f50", "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": "0006-0078", "generic_name": "sitagliptin and metformin hydrochloride", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "JANUMET", "brand_name_suffix": "XR", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}, {"name": "SITAGLIPTIN PHOSPHATE", "strength": "50 mg/1"}], "application_number": "NDA202270", "marketing_category": "NDA", "marketing_start_date": "20120202", "listing_expiration_date": "20261231"}