steglujan

Generic: ertugliflozin and sitagliptin

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

Drug Facts

Product Profile

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

ertugliflozin pidolate 15 mg/1, sitagliptin phosphate 100 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-5368
Product ID 0006-5368_232103cc-9755-4194-867a-8679e263905a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209805
Listing Expiration 2026-12-31
Marketing Start 2017-12-19

Pharmacologic Class

Classes
dipeptidyl peptidase 4 inhibitor [epc] dipeptidyl peptidase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00065368
Hyphenated Format 0006-5368

Supplemental Identifiers

RxCUI
1992826 1992832 1992835 1992837
UPC
0300065368030 0300065367033
UNII
TS63EW8X6F 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 steglujan (source: ndc)
Generic Name ertugliflozin and sitagliptin (source: ndc)
Application Number NDA209805 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0006-5368-03)
  • 90 TABLET, FILM COATED in 1 BOTTLE (0006-5368-06)
  • 500 TABLET, FILM COATED in 1 BOTTLE (0006-5368-07)
  • 2 BOTTLE in 1 CARTON (0006-5368-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5368-08)
source: ndc

Packages (4)

0006-5368-03 30 TABLET, FILM COATED in 1 BOTTLE (0006-5368-03) 0006-5368-06 90 TABLET, FILM COATED in 1 BOTTLE (0006-5368-06) 0006-5368-07 500 TABLET, FILM COATED in 1 BOTTLE (0006-5368-07) 0006-5368-09 2 BOTTLE in 1 CARTON (0006-5368-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5368-08)

Ingredients (2)

ertugliflozin pidolate (15 mg/1) sitagliptin phosphate (100 mg/1)

Linked Drug Pages (1)

STEGLUJAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "232103cc-9755-4194-867a-8679e263905a", "openfda": {"upc": ["0300065368030", "0300065367033"], "unii": ["TS63EW8X6F", "MLU731K321"], "rxcui": ["1992826", "1992832", "1992835", "1992837"], "spl_set_id": ["c2c553d8-5a9d-4366-bf53-8bdb5a876d19"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0006-5368-03)", "package_ndc": "0006-5368-03", "marketing_start_date": "20171219"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0006-5368-06)", "package_ndc": "0006-5368-06", "marketing_start_date": "20171219"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0006-5368-07)", "package_ndc": "0006-5368-07", "marketing_start_date": "20171219"}, {"sample": true, "description": "2 BOTTLE in 1 CARTON (0006-5368-09)  / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5368-08)", "package_ndc": "0006-5368-09", "marketing_start_date": "20171219"}], "brand_name": "STEGLUJAN", "product_id": "0006-5368_232103cc-9755-4194-867a-8679e263905a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "0006-5368", "generic_name": "ertugliflozin and sitagliptin", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "STEGLUJAN", "active_ingredients": [{"name": "ERTUGLIFLOZIN PIDOLATE", "strength": "15 mg/1"}, {"name": "SITAGLIPTIN PHOSPHATE", "strength": "100 mg/1"}], "application_number": "NDA209805", "marketing_category": "NDA", "marketing_start_date": "20171219", "listing_expiration_date": "20261231"}