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United States · US · US:42799-954_19147d81-49ac-463e-8643-26dace803ea5

Donepezil hydrochloride

Orange BookUNIISPLATC N06DA02

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

Identification

ManufacturerEdenbridge Pharmaceuticals LLC.
CountryUS (United States)
ATC codeN06DA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4279995401
    30 TABLET, FILM COATED in 1 BOTTLE (42799-954-01)
  • ndc11
    4279995402
    90 TABLET, FILM COATED in 1 BOTTLE (42799-954-02)

Annotations

UNII (FDA Substance ID)
3O2T2PJ89D
DONEPEZIL HYDROCHLORIDE
RxCUI 236559
Orange Book
A203713
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": "42799-954_19147d81-49ac-463e-8643-26dace803ea5",
  "productndc": "42799-954",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203713",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "23MG",
        "product_no": "001",
        "approval_date": "Feb 19, 2016"
      }
    ],
    "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": "ANDA203713",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Donepezil hydrochloride",
  "start_marketing_date": "20160219",
  "active_numerator_strength": "23"
}

Related drugs

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