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United States · US · US:59137-535_29d04017-dd64-4dea-a064-7b3b0805f423

Rasuvo

In shortageOrange BookUNIISPLATC L04AX03

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

Identification

ManufacturerMedexus Pharma Inc.
CountryUS (United States)
ATC codeL04AX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5913753501
    1 PACKAGE in 1 CARTON (59137-535-01) / .45 mL in 1 PACKAGE (59137-535-00)
  • ndc11
    5913753504
    4 PACKAGE in 1 CARTON (59137-535-04) / .45 mL in 1 PACKAGE (59137-535-00)

Annotations

UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
N205776
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methotrexate Sodium Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "3IG1E710ZN",
    "rxcui": "287734",
    "inchikey": "DASQOOZCTWOQPA-GXKRWWSZSA-L",
    "display_name": "METHOTREXATE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "d0075461-0e7e-4967-9c9b-d6440e912c0e": {
      "match": "brand_token",
      "title": "RASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDEXUS PHARMA INC.]",
      "spl_version": "10",
      "published_date": "2025-12-18"
    }
  },
  "productid": "59137-535_29d04017-dd64-4dea-a064-7b3b0805f423",
  "productndc": "59137-535",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "205776",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "7.5MG/0.15ML (7.5MG/0.15ML)",
        "product_no": "001",
        "approval_date": "Jul 10, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG/0.20ML (10MG/0.20ML)",
        "product_no": "002",
        "approval_date": "Jul 10, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "12.5MG/0.25ML (12.5MG/0.25ML)",
        "product_no": "003",
        "approval_date": "Jul 10, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "15MG/0.30ML (15MG/0.30ML)",
        "product_no": "004",
        "approval_date": "Jul 10, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "17.5MG/0.35ML (17.5MG/0.35ML)",
        "product_no": "005",
        "approval_date": "Jul 10, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG/0.4ML (20MG/0.4ML)",
        "product_no": "006",
        "approval_date": "Jul 10, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "22.5MG/0.45ML (22.5MG/0.45ML)",
        "product_no": "007",
        "approval_date": "Jul 10, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG/0.5ML (25MG/0.5ML)",
        "product_no": "008",
        "approval_date": "Jul 10, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "27.5MG/0.55ML (27.5MG/0.55ML)",
        "product_no": "009",
        "approval_date": "Jul 10, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "30MG/0.6ML (30MG/0.6ML)",
        "product_no": "010",
        "approval_date": "Jul 10, 2014"
      }
    ],
    "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": "Rasuvo",
  "active_ingred_unit": "mg/.45mL",
  "application_number": "NDA205776",
  "marketing_category": "NDA",
  "nonproprietary_name": "methotrexate",
  "start_marketing_date": "20140710",
  "active_numerator_strength": "22.5"
}

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