VIVITROL

Orange BookSPL

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

Identification

ManufacturerAlkermes, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6575730101
1 KIT in 1 CARTON (65757-301-01) * 4 mL in 1 VIAL, GLASS (65757-303-02) * 4 mL in 1 VIAL, GLASS (65757-305-03)

Annotations

Orange Book

N021897

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "cd11c435-b0f0-4bb9-ae78-60f101f3703f": {
      "match": "brand_token",
      "title": "VIVITROL (NALTREXONE) KIT [ALKERMES, INC.]",
      "spl_version": "38",
      "published_date": "2026-01-06"
    }
  },
  "productid": "65757-301_0f2da087-0d96-4978-9291-4ddf836fb7e5",
  "productndc": "65757-301",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "021897",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "380MG/VIAL",
        "product_no": "001",
        "approval_date": "Apr 13, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "VIVITROL",
  "active_ingred_unit": null,
  "application_number": "NDA021897",
  "marketing_category": "NDA",
  "nonproprietary_name": "naltrexone",
  "start_marketing_date": "20060613",
  "active_numerator_strength": null
}

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