Back to search
🇺🇸

United States · US · US:16729-277_2bae3cfe-7aa0-c14c-e063-6294a90a19f4

Methotrexate

In shortageOrange BookUNIISPLATC L04AX03

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

Identification

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

Packs · 3

  • ndc11
    1672927703
    1 VIAL in 1 CARTON (16729-277-03) / 10 mL in 1 VIAL
  • ndc11
    1672927730
    1 VIAL in 1 CARTON (16729-277-30) / 2 mL in 1 VIAL
  • ndc11
    1672927735
    1 VIAL in 1 CARTON (16729-277-35) / 40 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
YL5FZ2Y5U1
METHOTREXATE
RxCUI 6851
Orange Book
A040716
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": "16729-277_2bae3cfe-7aa0-c14c-e063-6294a90a19f4",
  "productndc": "16729-277",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "040716",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/40ML (EQ 25MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Apr 30, 2007"
      }
    ],
    "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": "ANDA040716",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methotrexate",
  "start_marketing_date": "20140307",
  "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.