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 ID: 55513-221_0065c77d-0a8e-48d8-8f1f-fc78f6cacc41
• NDC: 55513-221
• Product Type: Human Prescription Drug
• Proprietary Name: Nplate
• Generic Name: Romiplostim
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2008-08-25
• Marketing Category: BLA / BLA
• Application Number: BLA125268
• Labeler Name: Amgen Inc
• Substance Name: ROMIPLOSTIM
• Active Ingredient Strength: 250 ug/.5mL
• Pharm Classes: Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55513-221-01

1 VIAL in 1 CARTON (55513-221-01) > .5 mL in 1 VIAL

• Marketing Start Date: 2008-08-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-221-01 [55513022101]

Nplate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125268
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-08-25

Drug Details

Active Ingredients

Ingredient	Strength
ROMIPLOSTIM	250 ug/.5mL

OpenFDA Data

• SPL SET ID: c45f9a58-37c1-4f76-8e36-97d38c577037
• Manufacturer:
  • Amgen Inc
• UNII:
  • GN5XU2DXKV
• 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"

NDC	Brand Name	Generic Name
55513-221	Nplate	romiplostim
55513-222	Nplate	romiplostim
55513-223	Nplate	romiplostim