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United States · US · US:84054-015_4d40eab5-38f7-69a6-e063-6394a90a7fbd

ZUNVEYL

Orange BookUNIISPLATC N06DA

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

Identification

ManufacturerAlpha Cognition, Inc.
CountryUS (United States)
ATC codeN06DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8405401560
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (84054-015-60)

Annotations

UNII (FDA Substance ID)
XOI2Q0ZF7G
BENZGALANTAMINE
Orange Book
N218549
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "XOI2Q0ZF7G",
    "rxcui": null,
    "inchikey": "JKVNJTYHRABHIY-WXVUKLJWSA-N",
    "display_name": "BENZGALANTAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "af47bf67-1f07-4650-8064-24c38afc4656": {
      "match": "brand_token",
      "title": "ZUNVEYL (BENZGALANTAMINE) TABLET, DELAYED RELEASE [ALPHA COGNITION, INC.]",
      "spl_version": "5",
      "published_date": "2026-03-19"
    }
  },
  "productid": "84054-015_4d40eab5-38f7-69a6-e063-6394a90a7fbd",
  "productndc": "84054-015",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "218549",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 15MG BASE",
        "product_no": "003",
        "approval_date": "Jul 26, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZGALANTAMINE",
  "proprietary_name": "ZUNVEYL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218549",
  "marketing_category": "NDA",
  "nonproprietary_name": "benzgalantamine",
  "start_marketing_date": "20240809",
  "active_numerator_strength": "15"
}

Related drugs

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