Back to search
🇺🇸

United States · US · US:62332-730_f8955339-3c07-40ab-a866-ac75398ad2d6

METHOTREXATE

In shortageOrange BookUNIISPLATC L04AX03

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

Identification

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

Packs · 2

  • ndc11
    6233273031
    100 TABLET in 1 BOTTLE (62332-730-31)
  • ndc11
    6233273036
    36 TABLET in 1 BOTTLE (62332-730-36)

Annotations

UNII (FDA Substance ID)
3IG1E710ZN
METHOTREXATE SODIUM
RxCUI 287734
Orange Book
A217552
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": "62332-730_f8955339-3c07-40ab-a866-ac75398ad2d6",
  "productndc": "62332-730",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217552",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Jun 3, 2024"
      }
    ],
    "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": "ANDA217552",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METHOTREXATE",
  "start_marketing_date": "20240604",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code L04AX03.

Access this data programmatically

Query METHOTREXATE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.