nplate

Generic: romiplostim

Labeler: amgen, inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name nplate
Generic Name romiplostim
Labeler amgen, inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

romiplostim 125 ug/.25mL

Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-223
Product ID 55513-223_2a2c4ac6-ebb4-4019-8f2b-369c42df3d62
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125268
Listing Expiration 2026-12-31
Marketing Start 2019-08-02

Pharmacologic Class

Established (EPC)
thrombopoietin receptor agonist [epc]
Mechanism of Action
thrombopoietin receptor agonists [moa]
Physiologic Effect
increased megakaryocyte maturation [pe] increased platelet production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513223
Hyphenated Format 55513-223

Supplemental Identifiers

RxCUI
1728092 1728095 1728097 1728099 2201538 2201540
UPC
0355513221016 0355513222013
UNII
GN5XU2DXKV
NUI
N0000175969 N0000175970 N0000175973 N0000175968

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nplate (source: ndc)
Generic Name romiplostim (source: ndc)
Application Number BLA125268 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 125 ug/.25mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-01) / .25 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-21) / .25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

55513-223-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-01) / .25 mL in 1 VIAL, SINGLE-DOSE 55513-223-21 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-21) / .25 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

romiplostim (125 ug/.25mL)

Linked Drug Pages (1)

Nplate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "2a2c4ac6-ebb4-4019-8f2b-369c42df3d62", "openfda": {"nui": ["N0000175969", "N0000175970", "N0000175973", "N0000175968"], "upc": ["0355513221016", "0355513222013"], "unii": ["GN5XU2DXKV"], "rxcui": ["1728092", "1728095", "1728097", "1728099", "2201538", "2201540"], "spl_set_id": ["c45f9a58-37c1-4f76-8e36-97d38c577037"], "pharm_class_pe": ["Increased Megakaryocyte Maturation [PE]", "Increased Platelet Production [PE]"], "pharm_class_epc": ["Thrombopoietin Receptor Agonist [EPC]"], "pharm_class_moa": ["Thrombopoietin Receptor Agonists [MoA]"], "manufacturer_name": ["Amgen, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-01)  / .25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55513-223-01", "marketing_start_date": "20190802"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-21)  / .25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55513-223-21", "marketing_start_date": "20250801"}], "brand_name": "Nplate", "product_id": "55513-223_2a2c4ac6-ebb4-4019-8f2b-369c42df3d62", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Increased Megakaryocyte Maturation [PE]", "Increased Platelet Production [PE]", "Thrombopoietin Receptor Agonist [EPC]", "Thrombopoietin Receptor Agonists [MoA]"], "product_ndc": "55513-223", "generic_name": "romiplostim", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nplate", "active_ingredients": [{"name": "ROMIPLOSTIM", "strength": "125 ug/.25mL"}], "application_number": "BLA125268", "marketing_category": "BLA", "marketing_start_date": "20190802", "listing_expiration_date": "20261231"}