NDC 0006-5368

STEGLUJAN

Ertugliflozin And Sitagliptin

STEGLUJAN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Ertugliflozin Pidolate; Sitagliptin Phosphate.

Product ID0006-5368_011d786f-9fc8-4ded-8028-2513ace66bc6
NDC0006-5368
Product TypeHuman Prescription Drug
Proprietary NameSTEGLUJAN
Generic NameErtugliflozin And Sitagliptin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-12-19
Marketing CategoryNDA / NDA
Application NumberNDA209805
Labeler NameMerck Sharp & Dohme Corp.
Substance NameERTUGLIFLOZIN PIDOLATE; SITAGLIPTIN PHOSPHATE
Active Ingredient Strength15 mg/1; mg/1
Pharm ClassesDipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0006-5368-03

30 TABLET, FILM COATED in 1 BOTTLE (0006-5368-03)
Marketing Start Date2017-12-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-5368-06 [00006536806]

STEGLUJAN TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-19

NDC 0006-5368-09 [00006536809]

STEGLUJAN TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209805
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-19

NDC 0006-5368-07 [00006536807]

STEGLUJAN TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209805
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-19

NDC 0006-5368-03 [00006536803]

STEGLUJAN TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209805
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-19

NDC 0006-5368-08 [00006536808]

STEGLUJAN TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209805
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-19

Drug Details

Active Ingredients

IngredientStrength
ERTUGLIFLOZIN PIDOLATE15 mg/1

OpenFDA Data

SPL SET ID:c2c553d8-5a9d-4366-bf53-8bdb5a876d19
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1992832
  • 1992837
  • 1992835
  • 1992826
  • UPC Code
  • 0300065367033
  • 0300065368030
  • Pharmacological Class

    • Dipeptidyl Peptidase 4 Inhibitor [EPC]
    • Dipeptidyl Peptidase 4 Inhibitors [MoA]

    NDC Crossover Matching brand name "STEGLUJAN" or generic name "Ertugliflozin And Sitagliptin"

    NDCBrand NameGeneric Name
    0006-5367STEGLUJANertugliflozin and sitagliptin
    0006-5368STEGLUJANertugliflozin and sitagliptin

    Trademark Results [STEGLUJAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    STEGLUJAN
    STEGLUJAN
    86887773 5576254 Live/Registered
    Merck Sharp & Dohme Corp.
    2016-01-27

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