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United States · US · US:63323-609_53e20cb1-9e79-4c45-a5a7-62c3904df818

Enoxaparin Sodium

Orange BookUNIISPLATC B01AB05

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeB01AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332360990
    10 CELLO PACK in 1 CARTON (63323-609-90) / 1 SYRINGE in 1 CELLO PACK (63323-609-01) / .8 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
8NZ41MIK1O
ENOXAPARIN SODIUM
RxCUI 221095
Orange Book
N020164
APAPAPAPAPAPAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "8NZ41MIK1O",
    "rxcui": "221095",
    "inchikey": null,
    "display_name": "ENOXAPARIN SODIUM",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "5e7568a6-cf8a-4de2-86ba-b94c8ab4c806": {
      "match": "brand_token",
      "title": "ENOXAPARIN SODIUM INJECTION [CARDINAL HEALTH 107, LLC]",
      "spl_version": "7",
      "published_date": "2026-05-13"
    }
  },
  "productid": "63323-609_53e20cb1-9e79-4c45-a5a7-62c3904df818",
  "productndc": "63323-609",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020164",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "30MG/0.3ML (100MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 29, 1993"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "40MG/0.4ML (100MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 30, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "60MG/0.6ML (100MG/ML)",
        "product_no": "003",
        "approval_date": "Mar 27, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "80MG/0.8ML (100MG/ML)",
        "product_no": "004",
        "approval_date": "Mar 27, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100MG/ML (100MG/ML)",
        "product_no": "005",
        "approval_date": "Mar 27, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Jun 2, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "120MG/0.8ML (150MG/ML)",
        "product_no": "007",
        "approval_date": "Jun 2, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "150MG/ML (150MG/ML)",
        "product_no": "008",
        "approval_date": "Jun 2, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG/3ML (100MG/ML)",
        "product_no": "009",
        "approval_date": "Jan 23, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENOXAPARIN SODIUM",
  "proprietary_name": "Enoxaparin Sodium",
  "active_ingred_unit": "mg/.8mL",
  "application_number": "NDA020164",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "enoxaparin sodium",
  "start_marketing_date": "20190618",
  "active_numerator_strength": "120"
}

Related drugs

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