Donepezil

Orange BookUNIISPLATC N06DA02

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeN06DA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009026270
90 TABLET in 1 BOTTLE (50090-2627-0)

Annotations

UNII (FDA Substance ID)

3O2T2PJ89D

DONEPEZIL HYDROCHLORIDE

RxCUI 236559

Orange Book

A203034

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": {
    "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": "50090-2627_1eda014d-ec3c-4940-a6a2-3dfe24b07712",
  "productndc": "50090-2627",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203034",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jan 30, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DONEPEZIL HYDROCHLORIDE",
  "proprietary_name": "Donepezil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203034",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Donepezil hydrochloride",
  "start_marketing_date": "20150202",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06DA02.

Access this data programmatically

Query Donepezil and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs