Back to search
🇺🇸

United States · US · US:0143-9518_3046ff78-3565-46d1-a88b-283e5ff6e7c3

Methotrexate

In shortageOrange BookUNIISPLATC L04AX03

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

Identification

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

Packs · 1

  • ndc11
    0143951801
    1 VIAL in 1 BOX (0143-9518-01) / 4 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
YL5FZ2Y5U1
METHOTREXATE
RxCUI 6851
Orange Book
A089341
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methotrexate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "YL5FZ2Y5U1",
    "rxcui": "6851",
    "inchikey": "FBOZXECLQNJBKD-ZDUSSCGKSA-N",
    "display_name": "METHOTREXATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS",
  "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": "0143-9518_3046ff78-3565-46d1-a88b-283e5ff6e7c3",
  "productndc": "0143-9518",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "089341",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/4ML (EQ 25MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Sep 16, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOTREXATE",
  "shortage_reason": "Methotrexate Injection",
  "shortage_status": "current",
  "proprietary_name": "Methotrexate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA089341",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methotrexate",
  "start_marketing_date": "20180105",
  "active_numerator_strength": "25"
}

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.