Aricept

Orange BookUNIISPLATC N06DA02

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

Identification

ManufacturerEisai Inc.

CountryUS (United States)

ATC codeN06DA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6285624530
30 TABLET, FILM COATED in 1 BOTTLE (62856-245-30)

Annotations

UNII (FDA Substance ID)

3O2T2PJ89D

DONEPEZIL HYDROCHLORIDE

RxCUI 236559

Orange Book

N020690

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3O2T2PJ89D",
    "rxcui": "236559",
    "inchikey": "XWAIAVWHZJNZQQ-UHFFFAOYSA-N",
    "display_name": "DONEPEZIL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "98e451e1-e4d7-4439-a675-c5457ba20975": {
      "match": "brand_token",
      "title": "ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]",
      "spl_version": "31",
      "published_date": "2023-11-20"
    }
  },
  "productid": "62856-245_4bc1cba0-8ebe-4b11-b4a4-19148d4249c0",
  "productndc": "62856-245",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020690",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 25, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Nov 25, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DONEPEZIL HYDROCHLORIDE",
  "proprietary_name": "Aricept",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020690",
  "marketing_category": "NDA",
  "nonproprietary_name": "donepezil hydrochloride",
  "start_marketing_date": "19961125",
  "active_numerator_strength": "5"
}

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