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United States · US · US:63323-519_3bbbe74a-1246-41a6-9fc3-ca0230529b40

Heparin Sodium

In shortageOrange BookUNIISPLATC S01XA14

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeS01XA14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6332351910
    12 BAG in 1 CASE (63323-519-10) / 1000 mL in 1 BAG (63323-519-01)
  • ndc11
    6332351977
    24 BAG in 1 CASE (63323-519-77) / 500 mL in 1 BAG (63323-519-02)

Annotations

UNII (FDA Substance ID)
ZZ45AB24CA
HEPARIN SODIUM
RxCUI 9877
Orange Book
A212441
APAP
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",
  "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": "63323-519_3bbbe74a-1246-41a6-9fc3-ca0230529b40",
  "productndc": "63323-519",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212441",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200 UNITS/100ML",
        "product_no": "001",
        "approval_date": "Jul 24, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200 UNITS/100ML",
        "product_no": "002",
        "approval_date": "Jul 24, 2020"
      }
    ],
    "appl_type": "A"
  },
  "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]/100mL",
  "application_number": "ANDA212441",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Heparin Sodium",
  "start_marketing_date": "20200724",
  "active_numerator_strength": "200"
}

Related drugs

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