janumet

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

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

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-0577
Product ID 0006-0577_601dfad8-02f7-4696-9fe2-548610338dc9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022044
Listing Expiration 2026-12-31
Marketing Start 2007-03-30

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 00060577
Hyphenated Format 0006-0577

Supplemental Identifiers

RxCUI
861771 861821 2709488 2709491
UPC
0300060575617 0300060577611
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 (source: ndc)
Generic Name sitagliptin and metformin hydrochloride (source: ndc)
Application Number NDA022044 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 2 BOTTLE in 1 CARTON (0006-0577-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0577-02)
  • 4 POUCH in 1 CARTON (0006-0577-56) / 2 BLISTER PACK in 1 POUCH / 7 TABLET, FILM COATED in 1 BLISTER PACK
  • 60 TABLET, FILM COATED in 1 BOTTLE (0006-0577-61)
  • 180 TABLET, FILM COATED in 1 BOTTLE (0006-0577-62)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (0006-0577-82)
source: ndc

Packages (5)

0006-0577-03 2 BOTTLE in 1 CARTON (0006-0577-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0577-02) 0006-0577-56 4 POUCH in 1 CARTON (0006-0577-56) / 2 BLISTER PACK in 1 POUCH / 7 TABLET, FILM COATED in 1 BLISTER PACK 0006-0577-61 60 TABLET, FILM COATED in 1 BOTTLE (0006-0577-61) 0006-0577-62 180 TABLET, FILM COATED in 1 BOTTLE (0006-0577-62) 0006-0577-82 1000 TABLET, FILM COATED in 1 BOTTLE (0006-0577-82)

Ingredients (2)

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

Linked Drug Pages (1)

JANUMET ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "601dfad8-02f7-4696-9fe2-548610338dc9", "openfda": {"upc": ["0300060575617", "0300060577611"], "unii": ["TS63EW8X6F", "786Z46389E"], "rxcui": ["861771", "861821", "2709488", "2709491"], "spl_set_id": ["d19c7ed0-ad5c-426e-b2df-722508f97d67"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "2 BOTTLE in 1 CARTON (0006-0577-03)  / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0577-02)", "package_ndc": "0006-0577-03", "marketing_start_date": "20070330"}, {"sample": true, "description": "4 POUCH in 1 CARTON (0006-0577-56)  / 2 BLISTER PACK in 1 POUCH / 7 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0006-0577-56", "marketing_start_date": "20070330"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (0006-0577-61)", "package_ndc": "0006-0577-61", "marketing_start_date": "20070330"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (0006-0577-62)", "package_ndc": "0006-0577-62", "marketing_start_date": "20070330"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (0006-0577-82)", "package_ndc": "0006-0577-82", "marketing_start_date": "20070330"}], "brand_name": "JANUMET", "product_id": "0006-0577_601dfad8-02f7-4696-9fe2-548610338dc9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "0006-0577", "generic_name": "SITAGLIPTIN and METFORMIN HYDROCHLORIDE", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "JANUMET", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}, {"name": "SITAGLIPTIN PHOSPHATE", "strength": "50 mg/1"}], "application_number": "NDA022044", "marketing_category": "NDA", "marketing_start_date": "20070330", "listing_expiration_date": "20261231"}