NDC 0006-0277

JANUVIA

Sitagliptin

JANUVIA 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.

Product ID0006-0277_18128ec1-8748-4f68-a7e8-f004ec697b29
NDC0006-0277
Product TypeHuman Prescription Drug
Proprietary NameJANUVIA
Generic NameSitagliptin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2006-10-16
Marketing CategoryNDA / NDA
Application NumberNDA021995
Labeler NameMerck Sharp & Dohme Corp.
Substance NameSITAGLIPTIN PHOSPHATE
Active Ingredient Strength100 mg/1
Pharm ClassesDipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0006-0277-02

30 TABLET, FILM COATED in 1 DOSE PACK (0006-0277-02)
Marketing Start Date2006-10-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-0277-74 [00006027774]

JANUVIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-10-16
Marketing End Date2012-03-09

NDC 0006-0277-02 [00006027702]

JANUVIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021995
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-16

NDC 0006-0277-14 [00006027714]

JANUVIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-10-12

NDC 0006-0277-27 [00006027727]

JANUVIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-10-16
Marketing End Date2015-09-30

NDC 0006-0277-31 [00006027731]

JANUVIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021995
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-16

NDC 0006-0277-33 [00006027733]

JANUVIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021995
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-16

NDC 0006-0277-01 [00006027701]

JANUVIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021995
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-16

NDC 0006-0277-30 [00006027730]

JANUVIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-10-16
Marketing End Date2016-02-29

NDC 0006-0277-82 [00006027782]

JANUVIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021995
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-16

NDC 0006-0277-28 [00006027728]

JANUVIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021995
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-16

NDC 0006-0277-54 [00006027754]

JANUVIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021995
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-16

Drug Details

Active Ingredients

IngredientStrength
SITAGLIPTIN PHOSPHATE100 mg/1

OpenFDA Data

SPL SET ID:f85a48d0-0407-4c50-b0fa-7673a160bf01
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 665033
  • 665036
  • 665038
  • 665040
  • 665042
  • 665044
    • UPC Code
  • 0300060277313
  • 0300060112317
  • 0300060221316

    • Pharmacological Class

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

    NDC Crossover Matching brand name "JANUVIA" or generic name "Sitagliptin"

    NDCBrand NameGeneric Name
    0006-0112JANUVIAsitagliptin
    0006-0221JANUVIAsitagliptin
    0006-0277JANUVIAsitagliptin
    50090-3472JANUVIAsitagliptin
    50090-3527JANUVIAsitagliptin
    50090-4084JANUVIAsitagliptin
    50090-4086JANUVIAsitagliptin
    50090-4087JANUVIAsitagliptin
    50090-5517JANUVIAsitagliptin
    50090-5547JANUVIAsitagliptin
    50090-5585JANUVIAsitagliptin
    55154-5040JANUVIAsitagliptin
    55154-5042JANUVIAsitagliptin
    55154-5044JANUVIAJANUVIA

    Trademark Results [JANUVIA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    JANUVIA
    JANUVIA
    78833412 3621009 Live/Registered
    MERCK SHARP & DOHME CORP.
    2006-03-09
    JANUVIA
    JANUVIA
    76635570 3261637 Live/Registered
    MERCK SHARP & DOHME CORP.
    2005-04-07
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