NDC 55154-5040

JANUVIA

Sitagliptin

JANUVIA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health. The primary component is Sitagliptin Phosphate.

Product ID55154-5040_044fc35c-103c-4c88-83fd-936dbfa32a1c
NDC55154-5040
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 NameCardinal Health
Substance NameSITAGLIPTIN PHOSPHATE
Active Ingredient Strength50 mg/1
Pharm ClassesDipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 55154-5040-8

2340 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5040-8)
Marketing Start Date2006-10-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55154-5040-8 [55154504008]

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

Drug Details

Active Ingredients

IngredientStrength
SITAGLIPTIN PHOSPHATE50 mg/1

OpenFDA Data

SPL SET ID:39253ddd-0245-43b1-ad28-d5923983afb4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 665033
  • 665044
  • 665036
  • 665042
  • UPC Code
  • 0355154504127
  • 0355154504189
  • 0355154504080
  • 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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