NDC 55513-223

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 ID55513-223_155f0ec6-c4eb-4c3b-80e5-a0f8f0581eb2
NDC55513-223
Product TypeHuman Prescription Drug
Proprietary NameNplate
Generic NameRomiplostim
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-08-02
Marketing CategoryBLA / BLA
Application NumberBLA125268
Labeler NameAmgen Inc
Substance NameROMIPLOSTIM
Active Ingredient Strength125 ug/.25mL
Pharm ClassesIncreased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55513-223-01

1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-01) > .25 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-08-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55513-223-01 [55513022301]

Nplate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125268
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-02

Drug Details

Active Ingredients

IngredientStrength
ROMIPLOSTIM125 ug/.25mL

Pharmacological Class

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

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