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United States · US · US:50268-554_4992f7cb-30dc-6354-e063-6294a90a6784

Methotrexate

In shortageOrange BookUNIISPLATC L04AX03

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

Identification

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

Packs · 1

  • ndc11
    5026855415
    50 BLISTER PACK in 1 BOX (50268-554-15) / 1 TABLET in 1 BLISTER PACK (50268-554-11)

Annotations

UNII (FDA Substance ID)
YL5FZ2Y5U1
METHOTREXATE
RxCUI 6851
Orange Book
A207812
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methotrexate Sodium 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": {
    "9b34b1d8-d125-41a2-9f6f-3fab67b573bd": {
      "match": "brand_token",
      "title": "METHOTREXATE TABLET [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "16",
      "published_date": "2026-06-02"
    }
  },
  "productid": "50268-554_4992f7cb-30dc-6354-e063-6294a90a6784",
  "productndc": "50268-554",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207812",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Jan 13, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOTREXATE",
  "shortage_reason": "Methotrexate Sodium Injection",
  "shortage_status": "current",
  "proprietary_name": "Methotrexate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207812",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methotrexate",
  "start_marketing_date": "20260129",
  "active_numerator_strength": "2.5"
}

Related drugs

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