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United States · US · US:67046-1524_2f20d43e-a477-a839-e063-6394a90ace38

Methotrexate

In shortageOrange BookUNIISPLATC L04AX03

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

Identification

ManufacturerCoupler LLC
CountryUS (United States)
ATC codeL04AX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6704615243
    30 TABLET in 1 BLISTER PACK (67046-1524-3)

Annotations

UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A213343
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methotrexate 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": "ORAL",
  "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": "67046-1524_2f20d43e-a477-a839-e063-6394a90ace38",
  "productndc": "67046-1524",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213343",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Jan 24, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOTREXATE SODIUM",
  "shortage_reason": "Methotrexate Injection",
  "shortage_status": "current",
  "proprietary_name": "Methotrexate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213343",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methotrexate",
  "start_marketing_date": "20250227",
  "active_numerator_strength": "2.5"
}

Related drugs

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