NDC 54092-547

MOTEGRITY

Prucalopride

MOTEGRITY is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Prucalopride Succinate.

Product ID54092-547_36754500-401c-4066-8582-79d1261be5d8
NDC54092-547
Product TypeHuman Prescription Drug
Proprietary NameMOTEGRITY
Generic NamePrucalopride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-12-14
Marketing CategoryNDA / NDA
Application NumberNDA210166
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NamePRUCALOPRIDE SUCCINATE
Active Ingredient Strength2 mg/1
Pharm ClassesSerotonin-4 Receptor Agonist [EPC],Serotonin 4 Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 54092-547-01

30 TABLET, FILM COATED in 1 BOTTLE (54092-547-01)
Marketing Start Date2018-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-547-02 [54092054702]

MOTEGRITY TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-14

NDC 54092-547-01 [54092054701]

MOTEGRITY TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210166
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-14

NDC 54092-547-03 [54092054703]

MOTEGRITY TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-14

Drug Details

Active Ingredients

IngredientStrength
PRUCALOPRIDE SUCCINATE2 mg/1

OpenFDA Data

SPL SET ID:bca1e4c6-4b2b-4876-8ab3-654629c4ff1b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2107353
  • 2107351
  • 2107345
  • 2107355
  • NDC Crossover Matching brand name "MOTEGRITY" or generic name "Prucalopride"

    NDCBrand NameGeneric Name
    54092-546MOTEGRITYPRUCALOPRIDE
    54092-547MOTEGRITYPRUCALOPRIDE

    Trademark Results [MOTEGRITY]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MOTEGRITY
    MOTEGRITY
    87673187 5776458 Live/Registered
    Shire LLC
    2017-11-06
    MOTEGRITY
    MOTEGRITY
    87329871 5794940 Live/Registered
    Shire LLC
    2017-02-09

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