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United States · US · US:24979-004_625542d6-e84b-4a79-9c93-ab89bd9f5264

Donepezil Hydrochloride

Orange BookUNIISPLATC N06DA02

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeN06DA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2497900406
    30 TABLET, FILM COATED in 1 BOTTLE (24979-004-06)
  • ndc11
    2497900407
    90 TABLET, FILM COATED in 1 BOTTLE (24979-004-07)

Annotations

UNII (FDA Substance ID)
3O2T2PJ89D
DONEPEZIL HYDROCHLORIDE
RxCUI 236559
Orange Book
A203104
AB
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": {
    "12a755c5-1ad9-43d1-832a-eb2ff17bd693": {
      "match": "brand_token",
      "title": "DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "23",
      "published_date": "2026-06-02"
    }
  },
  "productid": "24979-004_625542d6-e84b-4a79-9c93-ab89bd9f5264",
  "productndc": "24979-004",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203104",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "23MG",
        "product_no": "001",
        "approval_date": "Oct 29, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DONEPEZIL HYDROCHLORIDE",
  "proprietary_name": "Donepezil Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203104",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Donepezil Hydrochloride",
  "start_marketing_date": "20150301",
  "active_numerator_strength": "23"
}

Related drugs

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