Arixtra

In shortageOrange BookUNIISPLATC B01AX05

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

Identification

ManufacturerMylan Institutional LLC

CountryUS (United States)

ATC codeB01AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6745759406
10 SYRINGE, GLASS in 1 CARTON (67457-594-06) / .6 mL in 1 SYRINGE, GLASS (67457-594-00)

Annotations

UNII (FDA Substance ID)

X0Q6N9USOZ

FONDAPARINUX SODIUM

RxCUI 322154

Orange Book

N021345

APAPAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Fondaparinux Sodium Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "X0Q6N9USOZ",
    "rxcui": "322154",
    "inchikey": "XEKSTYNIJLDDAZ-JASSWCPGSA-D",
    "display_name": "FONDAPARINUX SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "d3b30c68-cf45-4b46-8ba6-72090f7ba01a": {
      "match": "brand_token",
      "title": "ARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
      "spl_version": "13",
      "published_date": "2025-02-03"
    }
  },
  "productid": "67457-594_8de301f7-88ad-41d7-9ec3-884cab56f943",
  "productndc": "67457-594",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021345",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2.5MG/0.5ML (2.5MG/0.5ML)",
        "product_no": "001",
        "approval_date": "Dec 7, 2001"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5MG/0.4ML (5MG/0.4ML)",
        "product_no": "002",
        "approval_date": "May 28, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "7.5MG/0.6ML (7.5MG/0.6ML)",
        "product_no": "003",
        "approval_date": "May 28, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10MG/0.8ML (10MG/0.8ML)",
        "product_no": "004",
        "approval_date": "May 28, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FONDAPARINUX SODIUM",
  "shortage_reason": "Fondaparinux Sodium Injection",
  "shortage_status": "current",
  "proprietary_name": "Arixtra",
  "active_ingred_unit": "mg/.6mL",
  "application_number": "NDA021345",
  "marketing_category": "NDA",
  "nonproprietary_name": "fondaparinux sodium",
  "start_marketing_date": "20140519",
  "active_numerator_strength": "7.5"
}

Related drugs

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