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United States · US · US:55154-9585_cf6de552-021d-4221-b3de-f020f77cd959

Heparin Sodium

In shortageOrange BookUNIISPLATC S01XA14

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

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeS01XA14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515495855
    5 VIAL in 1 BAG (55154-9585-5) / 1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
ZZ45AB24CA
HEPARIN SODIUM
RxCUI 9877
Orange Book
N017029
APAPAPAPAPAPAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Heparin Sodium Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "ZZ45AB24CA",
    "rxcui": "9877",
    "inchikey": null,
    "display_name": "HEPARIN SODIUM",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "eede8a0c-5ae6-4166-84b3-12081405f08e": {
      "match": "brand_token",
      "title": "HEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM) INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "35",
      "published_date": "2026-05-26"
    }
  },
  "productid": "55154-9585_cf6de552-021d-4221-b3de-f020f77cd959",
  "productndc": "55154-9585",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "017029",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1,000 UNITS/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10,000 UNITS/ML",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20,000 UNITS/ML",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1,000 UNITS/ML",
        "product_no": "010",
        "approval_date": "Apr 28, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1,000 UNITS/ML",
        "product_no": "013",
        "approval_date": "Dec 5, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5,000 UNITS/ML",
        "product_no": "014",
        "approval_date": "Dec 5, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10,000 UNITS/ML",
        "product_no": "015",
        "approval_date": "Dec 5, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20,000 UNITS/ML",
        "product_no": "016",
        "approval_date": "Dec 5, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10,000 UNITS/ML",
        "product_no": "019",
        "approval_date": "Nov 22, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10,000 UNITS/ML",
        "product_no": "020",
        "approval_date": "Mar 31, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "40 UNITS/ML",
        "product_no": "021",
        "approval_date": "Aug 24, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50 UNITS/ML",
        "product_no": "022",
        "approval_date": "Aug 24, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100 UNITS/ML",
        "product_no": "023",
        "approval_date": "Aug 24, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50 UNITS/ML",
        "product_no": "024",
        "approval_date": "Aug 24, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100 UNITS/ML",
        "product_no": "025",
        "approval_date": "Aug 24, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HEPARIN SODIUM",
  "shortage_reason": "Heparin Sodium Injection",
  "shortage_status": "current",
  "proprietary_name": "Heparin Sodium",
  "active_ingred_unit": "[USP'U]/mL",
  "application_number": "NDA017029",
  "marketing_category": "NDA",
  "nonproprietary_name": "HEPARIN SODIUM",
  "start_marketing_date": "20200325",
  "active_numerator_strength": "5000"
}

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