NDC 65649-003

Trulance Immediate release

Plecanatide

Trulance Immediate release is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Salix Pharmaceuticals Inc.. The primary component is Plecanatide.

Product ID65649-003_32e16caa-3e71-476b-a394-faf189345e2b
NDC65649-003
Product TypeHuman Prescription Drug
Proprietary NameTrulance Immediate release
Generic NamePlecanatide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-02-21
Marketing CategoryNDA / NDA
Application NumberNDA208745
Labeler NameSalix Pharmaceuticals Inc.
Substance NamePLECANATIDE
Active Ingredient Strength3 mg/1
Pharm ClassesGuanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65649-003-01

1 BOTTLE in 1 CARTON (65649-003-01) > 1 TABLET in 1 BOTTLE
Marketing Start Date2017-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65649-003-07 [65649000307]

Trulance Immediate release TABLET
Marketing CategoryNDA
Application NumberNDA208745
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-21

NDC 65649-003-03 [65649000303]

Trulance Immediate release TABLET
Marketing CategoryNDA
Application NumberNDA208745
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-21

NDC 65649-003-30 [65649000330]

Trulance Immediate release TABLET
Marketing CategoryNDA
Application NumberNDA208745
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-21

NDC 65649-003-01 [65649000301]

Trulance Immediate release TABLET
Marketing CategoryNDA
Application NumberNDA208745
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-21

Drug Details

OpenFDA Data

SPL SET ID:fe2895bf-71a6-493a-b0ca-e06b2dfefc82
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1873757
  • 1873765
  • UPC Code
  • 0365649003301
  • Pharmacological Class

    • Guanylate Cyclase-C Agonist [EPC]
    • Guanylate Cyclase Activators [MoA]

    NDC Crossover Matching brand name "Trulance Immediate release" or generic name "Plecanatide"

    NDCBrand NameGeneric Name
    65649-003TrulancePlecanatide
    70194-003TrulancePlecanatide

    Trademark Results [Trulance]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TRULANCE
    TRULANCE
    87392678 5349314 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    2017-03-30
    TRULANCE
    TRULANCE
    87042213 5242709 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    2016-05-18

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