Donepezil Hydrochloride

Orange BookUNIISPLATC N06DA02

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

Identification

ManufacturerACI Healthcare USA, Inc.

CountryUS (United States)

ATC codeN06DA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7109312801
30 TABLET in 1 BOTTLE (71093-128-01)
ndc11
7109312803
90 TABLET in 1 BOTTLE (71093-128-03)
ndc11
7109312805
500 TABLET in 1 BOTTLE (71093-128-05)
ndc11
7109312806
1000 TABLET in 1 BOTTLE (71093-128-06)

Annotations

UNII (FDA Substance ID)

3O2T2PJ89D

DONEPEZIL HYDROCHLORIDE

RxCUI 236559

Orange Book

A078662

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": "71093-128_a4736add-da84-411f-8e6f-9de67bf467f8",
  "productndc": "71093-128",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078662",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 31, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "May 31, 2011"
      }
    ],
    "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": "ANDA078662",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Donepezil Hydrochloride",
  "start_marketing_date": "20210629",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06DA02.

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