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United States · US · US:0555-0572_7e149464-8aab-497b-ace5-21e4de160d88

Methotrexate

In shortageOrange BookUNIISPLATC L04AX03

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeL04AX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0555057202
    100 TABLET in 1 BOTTLE (0555-0572-02)
  • ndc11
    0555057235
    36 TABLET in 1 BOTTLE (0555-0572-35)

Annotations

UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A081099
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": "0555-0572_7e149464-8aab-497b-ace5-21e4de160d88",
  "productndc": "0555-0572",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "081099",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Oct 15, 1990"
      }
    ],
    "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": "ANDA081099",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methotrexate",
  "start_marketing_date": "19901101",
  "active_numerator_strength": "2.5"
}

Related drugs

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