Back to search
🇺🇸

United States · US · US:52652-2001_4e3b0925-2cdc-4743-91cf-860d98dd4661

Xatmep

In shortageOrange BookUNIISPLATC L04AX03

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

Identification

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

Packs · 2

  • ndc11
    5265220011
    120 mL in 1 BOTTLE (52652-2001-1)
  • ndc11
    5265220016
    60 mL in 1 BOTTLE (52652-2001-6)

Annotations

UNII (FDA Substance ID)
YL5FZ2Y5U1
METHOTREXATE
RxCUI 6851
Orange Book
N208400
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": "ORAL",
  "spl_meta": {
    "aec9984e-34c5-481b-b6bf-9bb5caf1daf8": {
      "match": "brand_token",
      "title": "XATMEP (METHOTREXATE) SOLUTION [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "12",
      "published_date": "2026-05-29"
    }
  },
  "productid": "52652-2001_4e3b0925-2cdc-4743-91cf-860d98dd4661",
  "productndc": "52652-2001",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "208400",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2.5MG BASE/ML",
        "product_no": "001",
        "approval_date": "Apr 25, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOTREXATE",
  "shortage_reason": "Methotrexate Injection",
  "shortage_status": "current",
  "proprietary_name": "Xatmep",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA208400",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methotrexate",
  "start_marketing_date": "20170501",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code L04AX03.

Access this data programmatically

Query Xatmep 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.