enoxaparin sodium

Orange BookUNIISPLATC B01AB05

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

Identification

ManufacturerHebei Changshan Biochemical Pharmaceutical Co., Ltd.

CountryUS (United States)

ATC codeB01AB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2895510410
10 SYRINGE in 1 CARTON (28955-104-10) / .8 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

8NZ41MIK1O

ENOXAPARIN SODIUM

RxCUI 221095

Orange Book

A218775

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": "28955-104_486592e2-4eef-525e-e063-6394a90a3048",
  "productndc": "28955-104",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "218775",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30MG/0.3ML (100MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 7, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MG/0.4ML (100MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 7, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "60MG/0.6ML (100MG/ML)",
        "product_no": "003",
        "approval_date": "Jan 7, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "80MG/0.8ML (100MG/ML)",
        "product_no": "004",
        "approval_date": "Jan 7, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML (100MG/ML)",
        "product_no": "005",
        "approval_date": "Jan 7, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "120MG/0.8ML (150MG/ML)",
        "product_no": "006",
        "approval_date": "Jan 7, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "150MG/ML (150MG/ML)",
        "product_no": "007",
        "approval_date": "Jan 7, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENOXAPARIN SODIUM",
  "proprietary_name": "enoxaparin sodium",
  "active_ingred_unit": "mg/.8mL",
  "application_number": "ANDA218775",
  "marketing_category": "ANDA",
  "nonproprietary_name": "enoxaparin sodium",
  "start_marketing_date": "20260501",
  "active_numerator_strength": "80"
}

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