NDC 0006-0577

JANUMET

Sitagliptin And Metformin Hydrochloride

JANUMET 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 Sitagliptin Phosphate; Metformin Hydrochloride.

Product ID0006-0577_51b7ac5d-0947-4d97-bd06-a56cb262145c
NDC0006-0577
Product TypeHuman Prescription Drug
Proprietary NameJANUMET
Generic NameSitagliptin And Metformin Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-03-30
Marketing CategoryNDA / NDA
Application NumberNDA022044
Labeler NameMerck Sharp & Dohme Corp.
Substance NameSITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
Active Ingredient Strength50 mg/1; mg/1
Pharm ClassesDipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0006-0577-03

2 BOTTLE in 1 CARTON (0006-0577-03) > 14 TABLET, FILM COATED in 1 BOTTLE (0006-0577-02)
Marketing Start Date2007-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-0577-02 [00006057702]

JANUMET TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-09

NDC 0006-0577-62 [00006057762]

JANUMET TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022044
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-03-30

NDC 0006-0577-01 [00006057701]

JANUMET TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-30

NDC 0006-0577-60 [00006057760]

JANUMET TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-31
Marketing End Date2015-09-09

NDC 0006-0577-61 [00006057761]

JANUMET TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022044
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-03-30

NDC 0006-0577-56 [00006057756]

JANUMET TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-30

NDC 0006-0577-82 [00006057782]

JANUMET TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022044
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-03-30

NDC 0006-0577-52 [00006057752]

JANUMET TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022044
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-03-30
Marketing End Date2011-10-05

NDC 0006-0577-03 [00006057703]

JANUMET TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-30

Drug Details

Active Ingredients

IngredientStrength
SITAGLIPTIN PHOSPHATE50 mg/1

OpenFDA Data

SPL SET ID:d19c7ed0-ad5c-426e-b2df-722508f97d67
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861771
  • 861819
  • 861769
  • 861821
    • UPC Code
  • 0300060575617
  • 0300060577611

    • Pharmacological Class

    • Dipeptidyl Peptidase 4 Inhibitor [EPC]
    • Dipeptidyl Peptidase 4 Inhibitors [MoA]
    • Biguanide [EPC]
    • Biguanides [CS]

    NDC Crossover Matching brand name "JANUMET" or generic name "Sitagliptin And Metformin Hydrochloride"

    NDCBrand NameGeneric Name
    0006-0078JANUMETsitagliptin and metformin hydrochloride
    0006-0080JANUMETsitagliptin and metformin hydrochloride
    0006-0081JANUMETsitagliptin and metformin hydrochloride
    0006-0575JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDE
    0006-0577JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDE
    50090-4411JANUMETsitagliptin and metformin hydrochloride
    50090-5618JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDE
    70518-2548JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDE

    Trademark Results [JANUMET]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    JANUMET
    JANUMET
    78934999 3363805 Live/Registered
    MERCK SHARP & DOHME CORP.
    2006-07-21
    JANUMET
    JANUMET
    78773912 3374065 Live/Registered
    MERCK SHARP & DOHME CORP.
    2005-12-15
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