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United States · US · US:0169-1302_852fff2d-704e-4b01-9244-439a28094202

Ozempic

Orange BookUNIISPLATC A10BJ06

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

Identification

ManufacturerNovo Nordisk Pharmaceutical Industries, LP
CountryUS (United States)
ATC codeA10BJ06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
53AXN4NNHX
SEMAGLUTIDE
RxCUI 1991302
Orange Book
N209637
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "53AXN4NNHX",
    "rxcui": "1991302",
    "inchikey": null,
    "display_name": "SEMAGLUTIDE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "adec4fd2-6858-4c99-91d4-531f5f2a2d79": {
      "match": "brand_token",
      "title": "OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK PHARMACEUTICAL INDUSTRIES, LP]",
      "spl_version": "19",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0169-1302_852fff2d-704e-4b01-9244-439a28094202",
  "productndc": "0169-1302",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209637",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2MG/1.5ML (1.34MG/ML)",
        "product_no": "001",
        "approval_date": "Dec 5, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4MG/3ML (1.34MG/ML)",
        "product_no": "002",
        "approval_date": "Apr 9, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "8MG/3ML (2.68MG/ML)",
        "product_no": "003",
        "approval_date": "Mar 28, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2MG/3ML (0.68MG/ML)",
        "product_no": "004",
        "approval_date": "Oct 6, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SEMAGLUTIDE",
  "proprietary_name": "Ozempic",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA209637",
  "marketing_category": "NDA",
  "nonproprietary_name": "semaglutide",
  "start_marketing_date": "20221007",
  "active_numerator_strength": ".25"
}

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