Heparin Sodium

In shortageOrange BookUNIISPLATC S01XA14

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeS01XA14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332354313
25 VIAL in 1 TRAY (63323-543-13) / .5 mL in 1 VIAL (63323-543-03)

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": "63323-543_e59b46ab-12ac-4ae9-bd13-3146984037e0",
  "productndc": "63323-543",
  "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        "strength": "5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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]/.5mL",
  "application_number": "NDA017029",
  "marketing_category": "NDA",
  "nonproprietary_name": "HEPARIN SODIUM",
  "start_marketing_date": "20191104",
  "active_numerator_strength": "5000"
}

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