METHOTREXATE

In shortageOrange BookUNIISPLATC L04AX03

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

Identification

ManufacturerEugia US LLC

CountryUS (United States)

ATC codeL04AX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5515051001
1 VIAL, SINGLE-DOSE in 1 CARTON (55150-510-01) / 2 mL in 1 VIAL, SINGLE-DOSE
ndc11
5515051005
5 VIAL, SINGLE-DOSE in 1 CARTON (55150-510-05) / 2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

3IG1E710ZN

METHOTREXATE SODIUM

RxCUI 287734

Orange Book

A201529

APAPAPAP

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": "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": "55150-510_adc6f7e8-b3a3-476a-9939-0c5cbda63dbd",
  "productndc": "55150-510",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "201529",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/2ML (EQ 25MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Mar 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/4ML (EQ 25MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Mar 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 200MG BASE/8ML (EQ 25MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Mar 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 250MG BASE/10ML (EQ 25MG BASE/ML)",
        "product_no": "004",
        "approval_date": "Mar 29, 2012"
      }
    ],
    "appl_type": "A"
  },
  "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/2mL",
  "application_number": "ANDA201529",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METHOTREXATE",
  "start_marketing_date": "20240911",
  "active_numerator_strength": "50"
}

Related drugs

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