Otrexup

In shortageOrange BookUNIISPLATC L04AX03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAntares Pharma, Inc.

CountryUS (United States)

ATC codeL04AX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5443601501
1 SYRINGE in 1 CARTON (54436-015-01) / .4 mL in 1 SYRINGE
ndc11
5443601503
1 SYRINGE in 1 CARTON (54436-015-03) / .4 mL in 1 SYRINGE
ndc11
5443601504
4 SYRINGE in 1 CARTON (54436-015-04) / .4 mL in 1 SYRINGE (54436-015-02)

Annotations

UNII (FDA Substance ID)

YL5FZ2Y5U1

METHOTREXATE

RxCUI 6851

Orange Book

N204824

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": "SUBCUTANEOUS",
  "spl_meta": {
    "9ab8ce16-f7de-41d4-a4c8-1c742621b6d5": {
      "match": "brand_token",
      "title": "OTREXUP (METHOTREXATE) INJECTION, SOLUTION [ANTARES PHARMA, INC.]",
      "spl_version": "15",
      "published_date": "2025-02-03"
    }
  },
  "productid": "54436-015_2d07eb50-d314-a6a0-e063-6394a90ac970",
  "productndc": "54436-015",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "204824",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG/0.4ML (10MG/0.4ML)",
        "product_no": "001",
        "approval_date": "Oct 11, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "15MG/0.4ML (15MG/0.4ML)",
        "product_no": "002",
        "approval_date": "Oct 11, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/0.4ML (20MG/0.4ML)",
        "product_no": "003",
        "approval_date": "Oct 11, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25MG/0.4ML (25MG/0.4ML)",
        "product_no": "004",
        "approval_date": "Oct 11, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "7.5MG/0.4ML (7.5MG/0.4ML)",
        "product_no": "005",
        "approval_date": "Nov 7, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "12.5MG/0.4ML (12.5MG/0.4ML)",
        "product_no": "006",
        "approval_date": "Mar 24, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "17.5MG/0.4ML (17.5MG/0.4ML)",
        "product_no": "007",
        "approval_date": "Mar 24, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "22.5MG/0.4ML (22.5MG/0.4ML)",
        "product_no": "008",
        "approval_date": "Mar 24, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG/0.4ML (10MG/0.4ML)",
        "product_no": "009",
        "approval_date": "May 31, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "15MG/0.6ML (15MG/0.6ML)",
        "product_no": "010",
        "approval_date": "May 31, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "17.5MG/0.7ML (17.5MG/0.7ML)",
        "product_no": "011",
        "approval_date": "May 31, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/0.8ML (20MG/0.8ML)",
        "product_no": "012",
        "approval_date": "May 31, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "22.5MG/0.9ML (22.5MG/0.9ML)",
        "product_no": "013",
        "approval_date": "May 31, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25MG/ML (25MG/ML)",
        "product_no": "014",
        "approval_date": "May 31, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOTREXATE",
  "shortage_reason": "Methotrexate Injection",
  "shortage_status": "current",
  "proprietary_name": "Otrexup",
  "active_ingred_unit": "mg/.4mL",
  "application_number": "NDA204824",
  "marketing_category": "NDA",
  "nonproprietary_name": "methotrexate",
  "start_marketing_date": "20131011",
  "active_numerator_strength": "15"
}

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