segluromet

Generic: ertugliflozin and metformin hydrochloride

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

Drug Facts

Product Profile

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

ertugliflozin pidolate 7.5 mg/1, metformin hydrochloride 1000 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-5374
Product ID 0006-5374_1981063d-b592-4847-ac6d-ba85722bd1d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209806
Listing Expiration 2026-12-31
Marketing Start 2017-12-19

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00065374
Hyphenated Format 0006-5374

Supplemental Identifiers

RxCUI
1992685 1992691 1992693 1992695 1992698 1992700 1992701 1992703
UPC
0300065373034 0300065370033 0300065374031 0300065369037
UNII
786Z46389E MLU731K321

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 segluromet (source: ndc)
Generic Name ertugliflozin and metformin hydrochloride (source: ndc)
Application Number NDA209806 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
  • 1000 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (0006-5374-03)
  • 180 TABLET, FILM COATED in 1 BOTTLE (0006-5374-06)
  • 500 TABLET, FILM COATED in 1 BOTTLE (0006-5374-07)
  • 2 BOTTLE in 1 CARTON (0006-5374-09) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-5374-08)
source: ndc

Packages (4)

Ingredients (2)

ertugliflozin pidolate (7.5 mg/1) metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "1981063d-b592-4847-ac6d-ba85722bd1d2", "openfda": {"upc": ["0300065373034", "0300065370033", "0300065374031", "0300065369037"], "unii": ["786Z46389E", "MLU731K321"], "rxcui": ["1992685", "1992691", "1992693", "1992695", "1992698", "1992700", "1992701", "1992703"], "spl_set_id": ["a6aeb99a-ce49-4125-90ce-642df3f1ebad"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (0006-5374-03)", "package_ndc": "0006-5374-03", "marketing_start_date": "20171219"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (0006-5374-06)", "package_ndc": "0006-5374-06", "marketing_start_date": "20171219"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0006-5374-07)", "package_ndc": "0006-5374-07", "marketing_start_date": "20171219"}, {"sample": true, "description": "2 BOTTLE in 1 CARTON (0006-5374-09)  / 14 TABLET, FILM COATED in 1 BOTTLE (0006-5374-08)", "package_ndc": "0006-5374-09", "marketing_start_date": "20171219"}], "brand_name": "SEGLUROMET", "product_id": "0006-5374_1981063d-b592-4847-ac6d-ba85722bd1d2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "0006-5374", "generic_name": "ertugliflozin and metformin hydrochloride", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SEGLUROMET", "active_ingredients": [{"name": "ERTUGLIFLOZIN PIDOLATE", "strength": "7.5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA209806", "marketing_category": "NDA", "marketing_start_date": "20171219", "listing_expiration_date": "20261231"}