Rybrevant Faspro

UNIISPLATC L01FX

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

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
5789452201
1 VIAL, SINGLE-DOSE in 1 CARTON (57894-522-01) / 22 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": "57894-522_e037897a-b42a-413f-8f3f-c0f5ee7b5125",
  "productndc": "57894-522",
  "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/22mL; mg/22mL",
  "application_number": "BLA761484",
  "marketing_category": "BLA",
  "nonproprietary_name": "AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT)",
  "start_marketing_date": "20260213",
  "active_numerator_strength": "3520; 44000"
}

Related drugs

Other records sharing ATC code L01FX.

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