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United States · US · US:57894-515_e037897a-b42a-413f-8f3f-c0f5ee7b5125

Rybrevant Faspro

UNIISPLATC L01FX

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerJanssen Biotech, Inc.
CountryUS (United States)
ATC codeL01FX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5789451501
    1 VIAL, SINGLE-DOSE in 1 CARTON (57894-515-01) / 15 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
0JSR7Z0NB6
AMIVANTAMAB
RxCUI 2549199
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0JSR7Z0NB6",
    "rxcui": "2549199",
    "inchikey": null,
    "display_name": "AMIVANTAMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "1466c070-9f97-4fa4-a955-6a6b59981fb8": {
      "match": "brand_token",
      "title": "RYBREVANT (AMIVANTAMAB-VMJW) INJECTION [JANSSEN BIOTECH, INC.]",
      "spl_version": "16",
      "published_date": "2026-03-18"
    }
  },
  "productid": "57894-515_e037897a-b42a-413f-8f3f-c0f5ee7b5125",
  "productndc": "57894-515",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMIVANTAMAB; HYALURONIDASE (HUMAN RECOMBINANT)",
  "proprietary_name": "Rybrevant Faspro",
  "active_ingred_unit": "mg/15mL; mg/15mL",
  "application_number": "BLA761484",
  "marketing_category": "BLA",
  "nonproprietary_name": "AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT)",
  "start_marketing_date": "20260213",
  "active_numerator_strength": "2400; 30000"
}

Related drugs

Other records sharing ATC code L01FX.

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