VYKOURA

Orange BookUNIISPLATC V03AF03

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

Identification

ManufacturerAvyxa Pharma, LLC

CountryUS (United States)

ATC codeV03AF03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8383114705
1 VIAL, SINGLE-USE in 1 CARTON (83831-147-05) / 5 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

RPR1R4C0P4

LEUCOVORIN CALCIUM

RxCUI 225852

Orange Book

N220406

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "RPR1R4C0P4",
    "rxcui": "225852",
    "inchikey": "KVUAALJSMIVURS-ZEDZUCNESA-L",
    "display_name": "LEUCOVORIN CALCIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "d122b875-435e-4e00-b945-7a0546df95c2": {
      "match": "brand_token",
      "title": "VYKOURA (LEUCOVORIN CALCIUM) INJECTION [AVYXA PHARMA, LLC]",
      "spl_version": "7",
      "published_date": "2026-03-16"
    }
  },
  "productid": "83831-147_c655613e-4381-461e-8e2d-4121be761c04",
  "productndc": "83831-147",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "220406",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE/5ML (EQ 10MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Feb 3, 2026"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 350MG BASE/35ML (EQ 10MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Feb 3, 2026"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 500MG BASE/50ML (EQ 10MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Feb 3, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEUCOVORIN CALCIUM",
  "proprietary_name": "VYKOURA",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA220406",
  "marketing_category": "NDA",
  "nonproprietary_name": "leucovorin calcium",
  "start_marketing_date": "20260316",
  "active_numerator_strength": "50"
}

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