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 ID: 55513-223_155f0ec6-c4eb-4c3b-80e5-a0f8f0581eb2
• NDC: 55513-223
• 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: 2019-08-02
• Marketing Category: BLA / BLA
• Application Number: BLA125268
• Labeler Name: Amgen Inc
• Substance Name: ROMIPLOSTIM
• Active Ingredient Strength: 125 ug/.25mL
• 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: 2022-12-31

Packaging

NDC 55513-223-01

1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-01) > .25 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-08-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-223-01 [55513022301]

Nplate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125268
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-02

Drug Details

Active Ingredients

Ingredient	Strength
ROMIPLOSTIM	125 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"

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