OZEMPIC

Orange BookUNIISPLATC A10BJ06

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

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 · 1

ndc11
0169170430
30 TABLET in 1 BOTTLE, PLASTIC (0169-1704-30)

Annotations

UNII (FDA Substance ID)

53AXN4NNHX

SEMAGLUTIDE

RxCUI 1991302

Orange Book

N213051

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": "ORAL",
  "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": "0169-1704_5176eed4-f8f8-4f88-a079-11f16864f40a",
  "productndc": "0169-1704",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213051",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3MG",
        "product_no": "001",
        "approval_date": "Sep 20, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "7MG",
        "product_no": "002",
        "approval_date": "Sep 20, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "14MG",
        "product_no": "003",
        "approval_date": "Sep 20, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.5MG",
        "product_no": "004",
        "approval_date": "Dec 9, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4MG",
        "product_no": "005",
        "approval_date": "Dec 9, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "9MG",
        "product_no": "006",
        "approval_date": "Dec 9, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SEMAGLUTIDE",
  "proprietary_name": "OZEMPIC",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA213051",
  "marketing_category": "NDA",
  "nonproprietary_name": "oral semaglutide",
  "start_marketing_date": "20260427",
  "active_numerator_strength": "4"
}

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