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United States · US · US:0075-0623_cdb74d6d-1a74-4156-a52a-710c55cb2927

Lovenox

Orange BookUNIISPLATC B01AB05

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

Identification

ManufacturerSanofi-Aventis U.S. LLC
CountryUS (United States)
ATC codeB01AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0075062300
    10 CELLO PACK in 1 CARTON (0075-0623-00) / 1 SYRINGE in 1 CELLO PACK (0075-0623-03) / 1 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": {
    "5017a927-2a24-4f27-89f9-27c805bf7d59": {
      "match": "brand_token",
      "title": "LOVENOX (ENOXAPARIN SODIUM) INJECTION [SANOFI-AVENTIS U.S. LLC]",
      "spl_version": "33",
      "published_date": "2026-05-29"
    }
  },
  "productid": "0075-0623_cdb74d6d-1a74-4156-a52a-710c55cb2927",
  "productndc": "0075-0623",
  "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": "Lovenox",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020164",
  "marketing_category": "NDA",
  "nonproprietary_name": "enoxaparin sodium",
  "start_marketing_date": "19930329",
  "active_numerator_strength": "100"
}

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