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United States · US · US:0264-3462_3d89e31c-d6f4-4b90-a97f-a6eb06b0d009

Heparin Sodium in Sodium Chloride

In shortageOrange BookUNIISPLATC S01XA14

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

Identification

ManufacturerB. Braun Medical Inc.
CountryUS (United States)
ATC codeS01XA14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0264346220
    24 CONTAINER in 1 CASE (0264-3462-20) / 250 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)
ZZ45AB24CA
HEPARIN SODIUM
RxCUI 9877
Orange Book
N019953
AP
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": "0264-3462_3d89e31c-d6f4-4b90-a97f-a6eb06b0d009",
  "productndc": "0264-3462",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "019953",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "200 UNITS/100ML",
        "product_no": "001",
        "approval_date": "Jul 20, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200 UNITS/100ML",
        "product_no": "002",
        "approval_date": "Dec 15, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5,000 UNITS/100ML",
        "product_no": "003",
        "approval_date": "Mar 25, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10,000 UNITS/100ML",
        "product_no": "004",
        "approval_date": "Mar 25, 2025"
      }
    ],
    "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 in Sodium Chloride",
  "active_ingred_unit": "[USP'U]/100mL",
  "application_number": "NDA019953",
  "marketing_category": "NDA",
  "nonproprietary_name": "Heparin Sodium in Sodium Chloride",
  "start_marketing_date": "20250718",
  "active_numerator_strength": "10000"
}

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