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United States · US · US:49702-264_cedc4b34-5c83-4d5f-a47f-7d5e93f71459

Apretude

Orange BookSPL

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

Identification

ManufacturerViiV Healthcare Company
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4970226423
    1 KIT in 1 CARTON (49702-264-23) * 3 mL in 1 VIAL (49702-238-03)

Annotations

Orange Book
N215499
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "4338428e-43d4-4e02-ac9d-bd98e738a7da": {
      "match": "brand_token",
      "title": "APRETUDE (CABOTEGRAVIR) KIT [VIIV HEALTHCARE COMPANY]",
      "spl_version": "8",
      "published_date": "2025-04-21"
    }
  },
  "productid": "49702-264_cedc4b34-5c83-4d5f-a47f-7d5e93f71459",
  "productndc": "49702-264",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "215499",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "600MG/3ML (200MG/ML)",
        "product_no": "001",
        "approval_date": "Dec 20, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Apretude",
  "active_ingred_unit": null,
  "application_number": "NDA215499",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cabotegravir",
  "start_marketing_date": "20211220",
  "active_numerator_strength": null
}

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