JYLAMVO

In shortageOrange BookUNIISPLATC L04AX03

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

Identification

ManufacturerSHORLA ONCOLOGY INC.

CountryUS (United States)

ATC codeL04AX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8192720401
1 BOTTLE, GLASS in 1 CARTON (81927-204-01) / 60 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)

YL5FZ2Y5U1

METHOTREXATE

RxCUI 6851

Orange Book

N212479

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Methotrexate Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "YL5FZ2Y5U1",
    "rxcui": "6851",
    "inchikey": "FBOZXECLQNJBKD-ZDUSSCGKSA-N",
    "display_name": "METHOTREXATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "96e931f5-51ae-4bdf-a441-bb0dd26d4c0e": {
      "match": "brand_token",
      "title": "JYLAMVO (METHOTREXATE) SOLUTION [SHORLA ONCOLOGY INC.]",
      "spl_version": "10",
      "published_date": "2025-12-22"
    }
  },
  "productid": "81927-204_3a5966e9-256b-4595-b962-e00d07526623",
  "productndc": "81927-204",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "212479",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "Nov 29, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOTREXATE",
  "shortage_reason": "Methotrexate Injection",
  "shortage_status": "current",
  "proprietary_name": "JYLAMVO",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA212479",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methotrexate",
  "start_marketing_date": "20231215",
  "active_numerator_strength": "2"
}

Related drugs

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