Nplate

UNIISPLATC B02BX04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAmgen, Inc

CountryUS (United States)

ATC codeB02BX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5551322301
1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-01) / .25 mL in 1 VIAL, SINGLE-DOSE
ndc11
5551322321
1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-21) / .25 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

GN5XU2DXKV

ROMIPLOSTIM

RxCUI 805452

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "GN5XU2DXKV",
    "rxcui": "805452",
    "inchikey": null,
    "display_name": "ROMIPLOSTIM",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "c45f9a58-37c1-4f76-8e36-97d38c577037": {
      "match": "brand_token",
      "title": "NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN, INC]",
      "spl_version": "161",
      "published_date": "2026-03-12"
    }
  },
  "productid": "55513-223_74d31919-0ed2-4e98-abd8-7cc3e011646b",
  "productndc": "55513-223",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROMIPLOSTIM",
  "proprietary_name": "Nplate",
  "active_ingred_unit": "ug/.25mL",
  "application_number": "BLA125268",
  "marketing_category": "BLA",
  "nonproprietary_name": "romiplostim",
  "start_marketing_date": "20190802",
  "active_numerator_strength": "125"
}

Related drugs

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