NDC 59572-503

Pomalyst

Pomalidomide

Pomalyst is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Celgene Corporation. The primary component is Pomalidomide.

Product ID59572-503_0e50dfc9-35ac-4b11-89f1-5c3653717c3d
NDC59572-503
Product TypeHuman Prescription Drug
Proprietary NamePomalyst
Generic NamePomalidomide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2013-02-18
Marketing CategoryNDA / NDA
Application NumberNDA204026
Labeler NameCelgene Corporation
Substance NamePOMALIDOMIDE
Active Ingredient Strength3 mg/1
Pharm ClassesThalidomide Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59572-503-00

100 CAPSULE in 1 BOTTLE (59572-503-00)
Marketing Start Date2013-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59572-503-21 [59572050321]

Pomalyst CAPSULE
Marketing CategoryNDA
Application NumberNDA204026
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-02-18

NDC 59572-503-00 [59572050300]

Pomalyst CAPSULE
Marketing CategoryNDA
Application NumberNDA204026
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-02-18

Drug Details

Active Ingredients

IngredientStrength
POMALIDOMIDE3 mg/1

OpenFDA Data

SPL SET ID:2b25ef01-5c9e-11e1-b86c-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1369718
  • 1369734
  • 1369726
  • 1369736
  • 1369724
  • 1369730
  • 1369732
  • 1369728
  • UPC Code
  • 0359572504004
  • Pharmacological Class

    • Thalidomide Analog [EPC]

    NDC Crossover Matching brand name "Pomalyst" or generic name "Pomalidomide"

    NDCBrand NameGeneric Name
    59572-501Pomalystpomalidomide
    59572-502Pomalystpomalidomide
    59572-503Pomalystpomalidomide
    59572-504Pomalystpomalidomide

    Trademark Results [Pomalyst]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    POMALYST
    POMALYST
    85885565 4388257 Live/Registered
    Celgene Corporation
    2013-03-25
    POMALYST
    POMALYST
    85150878 3980998 Live/Registered
    Celgene Corporation
    2010-10-12

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