NDC 0006-0081

JANUMET XR

Sitagliptin And Metformin Hydrochloride

JANUMET XR is a Oral Tablet, Film Coated, Extended Release 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 ID0006-0081_34c2aa5e-b8e0-4e56-ad12-6aa8aa4134ff
NDC0006-0081
Product TypeHuman Prescription Drug
Proprietary NameJANUMET XR
Generic NameSitagliptin And Metformin Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-02-02
Marketing CategoryNDA / NDA
Application NumberNDA202270
Labeler NameMerck Sharp & Dohme Corp.
Substance NameSITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
Active Ingredient Strength100 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 0006-0081-14

2 BOTTLE in 1 CARTON (0006-0081-14) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0081-07)
Marketing Start Date2012-02-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-0081-82 [00006008182]

JANUMET XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA202270
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-02

NDC 0006-0081-07 [00006008107]

JANUMET XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA202270
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-02

NDC 0006-0081-31 [00006008131]

JANUMET XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA202270
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-02

NDC 0006-0081-54 [00006008154]

JANUMET XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA202270
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-02

NDC 0006-0081-14 [00006008114]

JANUMET XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA202270
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-02

Drug Details

Active Ingredients

IngredientStrength
SITAGLIPTIN PHOSPHATE100 mg/1

OpenFDA Data

SPL SET ID:64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1243833
  • 1243827
  • 1243848
  • 1243843
  • 1243842
  • 1243846
  • UPC Code
  • 0300060081316
  • 0300060080616
  • 0300060078613
  • Pharmacological Class

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

    NDC Crossover Matching brand name "JANUMET XR" 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.