steglatro

Generic: ertugliflozin

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

Drug Facts

Product Profile

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

ertugliflozin pidolate 15 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-5364
Product ID 0006-5364_1616eabd-2ed5-4a98-b255-964e73b63dc8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209803
Listing Expiration 2026-12-31
Marketing Start 2017-12-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00065364
Hyphenated Format 0006-5364

Supplemental Identifiers

RxCUI
1992810 1992816 1992819 1992821
UPC
0300065363035 0300065364032
UNII
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 steglatro (source: ndc)
Generic Name ertugliflozin (source: ndc)
Application Number NDA209803 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0006-5364-03)
  • 90 TABLET, FILM COATED in 1 BOTTLE (0006-5364-06)
  • 500 TABLET, FILM COATED in 1 BOTTLE (0006-5364-07)
  • 2 BOTTLE in 1 CARTON (0006-5364-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5364-08)
source: ndc

Packages (4)

0006-5364-03 30 TABLET, FILM COATED in 1 BOTTLE (0006-5364-03) 0006-5364-06 90 TABLET, FILM COATED in 1 BOTTLE (0006-5364-06) 0006-5364-07 500 TABLET, FILM COATED in 1 BOTTLE (0006-5364-07) 0006-5364-09 2 BOTTLE in 1 CARTON (0006-5364-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5364-08)

Ingredients (1)

ertugliflozin pidolate (15 mg/1)

Linked Drug Pages (1)

STEGLATRO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1616eabd-2ed5-4a98-b255-964e73b63dc8", "openfda": {"upc": ["0300065363035", "0300065364032"], "unii": ["MLU731K321"], "rxcui": ["1992810", "1992816", "1992819", "1992821"], "spl_set_id": ["e6f3e718-bb99-48f1-ab94-b9f0af05fed6"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0006-5364-03)", "package_ndc": "0006-5364-03", "marketing_start_date": "20171219"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0006-5364-06)", "package_ndc": "0006-5364-06", "marketing_start_date": "20171219"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0006-5364-07)", "package_ndc": "0006-5364-07", "marketing_start_date": "20171219"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (0006-5364-09)  / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5364-08)", "package_ndc": "0006-5364-09", "marketing_start_date": "20171219"}], "brand_name": "STEGLATRO", "product_id": "0006-5364_1616eabd-2ed5-4a98-b255-964e73b63dc8", "dosage_form": "TABLET, FILM COATED", "product_ndc": "0006-5364", "generic_name": "ertugliflozin", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "STEGLATRO", "active_ingredients": [{"name": "ERTUGLIFLOZIN PIDOLATE", "strength": "15 mg/1"}], "application_number": "NDA209803", "marketing_category": "NDA", "marketing_start_date": "20171219", "listing_expiration_date": "20261231"}