Methotrexate

{
  "unii": {
    "unii": "3IG1E710ZN",
    "rxcui": "287734",
    "inchikey": "DASQOOZCTWOQPA-GXKRWWSZSA-L",
    "display_name": "METHOTREXATE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "9b34b1d8-d125-41a2-9f6f-3fab67b573bd": {
      "match": "brand_token",
      "title": "METHOTREXATE TABLET [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "16",
      "published_date": "2026-06-02"
    }
  },
  "productid": "61703-161_6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910",
  "productndc": "61703-161",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "011719",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2.5MG BASE/ML",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE/ML",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE/ML",
        "product_no": "007",
        "approval_date": "Mar 31, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "009",
        "approval_date": "Apr 7, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/2ML (EQ 25MG BASE/ML)",
        "product_no": "010",
        "approval_date": "Dec 15, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)",
        "product_no": "011",
        "approval_date": "Apr 13, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/40ML (EQ 25MG BASE/ML)",
        "product_no": "012",
        "approval_date": "Apr 13, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "013",
        "approval_date": "Apr 13, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE/2ML (EQ 10MG BASE/ML)",
        "product_no": "014",
        "approval_date": "Apr 13, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOTREXATE SODIUM",
  "shortage_reason": "Methotrexate Sodium Injection",
  "shortage_status": "current",
  "proprietary_name": "Methotrexate",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA011719",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methotrexate",
  "start_marketing_date": "20241104",
  "active_numerator_strength": "25"
}