fondaparinux sodium

In shortageOrange BookUNIISPLATC B01AX05

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

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.

CountryUS (United States)

ATC codeB01AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7071015166
10 SYRINGE in 1 CARTON (70710-1516-6) / .6 mL in 1 SYRINGE (70710-1516-2)
ndc11
7071015169
2 SYRINGE in 1 CARTON (70710-1516-9) / .6 mL in 1 SYRINGE (70710-1516-2)

Annotations

UNII (FDA Substance ID)

X0Q6N9USOZ

FONDAPARINUX SODIUM

RxCUI 322154

Orange Book

A208615

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": "70710-1516_4234bd9e-7f61-2cb0-e063-6294a90a4e14",
  "productndc": "70710-1516",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "208615",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2.5MG/0.5ML (2.5MG/0.5ML)",
        "product_no": "001",
        "approval_date": "Nov 14, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5MG/0.4ML (5MG/0.4ML)",
        "product_no": "002",
        "approval_date": "Nov 14, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "7.5MG/0.6ML (7.5MG/0.6ML)",
        "product_no": "003",
        "approval_date": "Nov 14, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/0.8ML (10MG/0.8ML)",
        "product_no": "004",
        "approval_date": "Nov 14, 2018"
      }
    ],
    "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": "ANDA208615",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fondaparinux sodium",
  "start_marketing_date": "20190206",
  "active_numerator_strength": "7.5"
}

Related drugs

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