Fragmin

{
  "unii": {
    "unii": "12M44VTJ7B",
    "rxcui": "82137",
    "inchikey": null,
    "display_name": "DALTEPARIN SODIUM",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "23527b8b-9b28-4e6d-9751-33b143975ac7": {
      "match": "brand_token",
      "title": "FRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "27",
      "published_date": "2025-10-02"
    }
  },
  "productid": "0069-0220_af340f13-7954-4974-845d-ae55e0b56512",
  "productndc": "0069-0220",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020287",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2,500IU/0.2ML (12,500IU/ML)",
        "product_no": "001",
        "approval_date": "Dec 22, 1994"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10,000IU/0.4ML (25,000IU/ML)",
        "product_no": "002",
        "approval_date": "May 1, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5,000IU/0.2ML (25,000IU/ML)",
        "product_no": "003",
        "approval_date": "Mar 18, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10,000IU/ML (10,000IU/ML)",
        "product_no": "004",
        "approval_date": "Jan 30, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "7,500IU/0.3ML (25,000IU/ML)",
        "product_no": "005",
        "approval_date": "Apr 4, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "95,000IU/3.8ML (25,000IU/ML)",
        "product_no": "006",
        "approval_date": "Apr 4, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "95,000IU/9.5ML (10,000IU/ML)",
        "product_no": "007",
        "approval_date": "Apr 4, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "7,500 IU/0.75ML",
        "product_no": "008",
        "approval_date": "Apr 4, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "12,500IU/0.5ML (25,000IU/ML)",
        "product_no": "009",
        "approval_date": "May 1, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "15,000IU/0.6ML (25,000IU/ML)",
        "product_no": "010",
        "approval_date": "May 1, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "18,000IU/0.72ML (25,000IU/ML)",
        "product_no": "011",
        "approval_date": "May 1, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10,000IU/4ML (2,500IU/ML)",
        "product_no": "012",
        "approval_date": "Mar 15, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DALTEPARIN SODIUM",
  "proprietary_name": "Fragmin",
  "active_ingred_unit": "[iU]/.5mL",
  "application_number": "NDA020287",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dalteparin Sodium",
  "start_marketing_date": "20150401",
  "active_numerator_strength": "12500"
}