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United States · US · US:81952-116_2e8e07a4-763e-79e5-e063-6394a90a7619

Heparin Sodium

In shortageOrange BookUNIISPLATC S01XA14

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

Identification

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

Packs · 1

  • ndc11
    8195211606
    25 VIAL, MULTI-DOSE in 1 CARTON (81952-116-06) / 1 mL in 1 VIAL, MULTI-DOSE (81952-116-01)

Annotations

UNII (FDA Substance ID)
ZZ45AB24CA
HEPARIN SODIUM
RxCUI 9877
Orange Book
A203198
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; 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": "81952-116_2e8e07a4-763e-79e5-e063-6394a90a7619",
  "productndc": "81952-116",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "203198",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10,000 UNITS/ML",
        "product_no": "001",
        "approval_date": "Jun 12, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20,000 UNITS/ML",
        "product_no": "002",
        "approval_date": "Jun 12, 2014"
      }
    ],
    "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]/mL",
  "application_number": "ANDA203198",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Heparin Sodium",
  "start_marketing_date": "20140612",
  "active_numerator_strength": "20000"
}

Related drugs

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