Enoxaparin Sodium

Orange BookUNIISPLATC B01AB05

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

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
6332358696
10 BLISTER PACK in 1 CARTON (63323-586-96) / 1 SYRINGE in 1 BLISTER PACK (63323-586-21) / 1 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

8NZ41MIK1O

ENOXAPARIN SODIUM

RxCUI 221095

Orange Book

A078990

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": "63323-586_db998293-f7be-4d13-b2bf-bd8ec2acdc89",
  "productndc": "63323-586",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "078990",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30MG/0.3ML (100MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 28, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MG/0.4ML (100MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 28, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "60MG/0.6ML (100MG/ML)",
        "product_no": "003",
        "approval_date": "Sep 28, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "80MG/0.8ML (100MG/ML)",
        "product_no": "004",
        "approval_date": "Sep 28, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML (100MG/ML)",
        "product_no": "005",
        "approval_date": "Sep 28, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "120MG/0.8ML (150MG/ML)",
        "product_no": "006",
        "approval_date": "Sep 28, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "150MG/ML (150MG/ML)",
        "product_no": "007",
        "approval_date": "Sep 28, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENOXAPARIN SODIUM",
  "proprietary_name": "Enoxaparin Sodium",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078990",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Enoxaparin Sodium",
  "start_marketing_date": "20190423",
  "active_numerator_strength": "100"
}

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