NDC 55513-221

Nplate

Romiplostim

Nplate is a Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Romiplostim.

Product ID55513-221_0065c77d-0a8e-48d8-8f1f-fc78f6cacc41
NDC55513-221
Product TypeHuman Prescription Drug
Proprietary NameNplate
Generic NameRomiplostim
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2008-08-25
Marketing CategoryBLA / BLA
Application NumberBLA125268
Labeler NameAmgen Inc
Substance NameROMIPLOSTIM
Active Ingredient Strength250 ug/.5mL
Pharm ClassesIncreased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55513-221-01

1 VIAL in 1 CARTON (55513-221-01) > .5 mL in 1 VIAL
Marketing Start Date2008-08-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55513-221-01 [55513022101]

Nplate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125268
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-08-25

Drug Details

Active Ingredients

IngredientStrength
ROMIPLOSTIM250 ug/.5mL

OpenFDA Data

SPL SET ID:c45f9a58-37c1-4f76-8e36-97d38c577037
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1728097
  • 1728095
  • 1728092
  • 1728099
  • UPC Code
  • 0355513222013
  • 0355513221016
  • Pharmacological Class

    • Increased Megakaryocyte Maturation [PE]
    • Increased Platelet Production [PE]
    • Thrombopoietin Receptor Agonist [EPC]
    • Thrombopoietin Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Nplate" or generic name "Romiplostim"

    NDCBrand NameGeneric Name
    55513-221Nplateromiplostim
    55513-222Nplateromiplostim
    55513-223Nplateromiplostim

    Trademark Results [Nplate]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NPLATE
    NPLATE
    78732010 3574008 Live/Registered
    Amgen Inc.
    2005-10-12

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