FONDAPARINUX SODIUM

In shortageOrange BookUNIISPLATC B01AX05

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

Identification

ManufacturerEugia US LLC

CountryUS (United States)

ATC codeB01AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5515023202
2 SYRINGE, GLASS in 1 CARTON (55150-232-02) / .6 mL in 1 SYRINGE, GLASS (55150-232-00)
ndc11
5515023210
10 SYRINGE, GLASS in 1 CARTON (55150-232-10) / .6 mL in 1 SYRINGE, GLASS (55150-232-00)

Annotations

UNII (FDA Substance ID)

X0Q6N9USOZ

FONDAPARINUX SODIUM

RxCUI 322154

Orange Book

A206918

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": {
    "dffbf7c9-495e-4a33-ac76-57b52f014fc2": {
      "match": "brand_token",
      "title": "FONDAPARINUX SODIUM INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS (USA) INC.]",
      "spl_version": "20",
      "published_date": "2025-11-17"
    }
  },
  "productid": "55150-232_a193830a-dc25-412a-b047-d2fa77d9dbbc",
  "productndc": "55150-232",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "206918",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2.5MG/0.5ML (2.5MG/0.5ML)",
        "product_no": "001",
        "approval_date": "Dec 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5MG/0.4ML (5MG/0.4ML)",
        "product_no": "002",
        "approval_date": "Dec 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "7.5MG/0.6ML (7.5MG/0.6ML)",
        "product_no": "003",
        "approval_date": "Dec 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/0.8ML (10MG/0.8ML)",
        "product_no": "004",
        "approval_date": "Dec 26, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FONDAPARINUX SODIUM",
  "shortage_reason": "Fondaparinux Sodium Injection",
  "shortage_status": "current",
  "proprietary_name": "FONDAPARINUX SODIUM",
  "active_ingred_unit": "mg/.6mL",
  "application_number": "ANDA206918",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FONDAPARINUX SODIUM",
  "start_marketing_date": "20171226",
  "active_numerator_strength": "7.5"
}

Related drugs

Other records sharing ATC code B01AX05.

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