Nexplanon

Orange BookUNIISPLATC G03AC08

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

Identification

ManufacturerOrganon LLC

CountryUS (United States)

ATC codeG03AC08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7820614501
1 BLISTER PACK in 1 CARTON (78206-145-01) / 1 IMPLANT in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

304GTH6RNH

ETONOGESTREL

RxCUI 14584

Orange Book

N021529

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "304GTH6RNH",
    "rxcui": "14584",
    "inchikey": "GCKFUYQCUCGESZ-BPIQYHPVSA-N",
    "display_name": "ETONOGESTREL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "487f8a62-e142-457c-97cc-2e398fde7594": {
      "match": "brand_token",
      "title": "NEXPLANON (ETONOGESTREL) IMPLANT [ORGANON LLC]",
      "spl_version": "11",
      "published_date": "2026-01-23"
    }
  },
  "productid": "78206-145_11bdb463-b672-4e94-993d-bd1b22dc6654",
  "productndc": "78206-145",
  "dosage_form": "IMPLANT",
  "orange_book": {
    "appl_no": "021529",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "68MG/IMPLANT",
        "product_no": "001",
        "approval_date": "Jul 17, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "68MG/IMPLANT",
        "product_no": "002",
        "approval_date": "May 13, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETONOGESTREL",
  "proprietary_name": "Nexplanon",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021529",
  "marketing_category": "NDA",
  "nonproprietary_name": "etonogestrel",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "68"
}

Related drugs

Other records sharing ATC code G03AC08.

Access this data programmatically

Query Nexplanon and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs