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United States · US · US:49702-266_15253b2a-c96c-489c-be6d-b37fcb63ad5b

Cabenuva

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
    4970226663
    1 KIT in 1 CARTON (49702-266-63) * 3 mL in 1 VIAL (49702-238-64) * 3 mL in 1 VIAL (49702-243-61)

Annotations

Orange Book
N212888
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "1698baf3-f895-4c42-a1b1-e9ee3f20da36": {
      "match": "brand_token",
      "title": "CABENUVA (CABOTEGRAVIR AND RILPIVIRINE) KIT [VIIV HEALTHCARE COMPANY]",
      "spl_version": "16",
      "published_date": "2025-12-05"
    }
  },
  "productid": "49702-266_15253b2a-c96c-489c-be6d-b37fcb63ad5b",
  "productndc": "49702-266",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "212888",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 21, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 21, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Cabenuva",
  "active_ingred_unit": null,
  "application_number": "NDA212888",
  "marketing_category": "NDA",
  "nonproprietary_name": "cabotegravir and rilpivirine",
  "start_marketing_date": "20250121",
  "active_numerator_strength": null
}

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