Donepezil Hydrochloride

Orange BookUNIISPLATC N06DA02

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN06DA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7120594800
100 TABLET, FILM COATED in 1 BOTTLE (71205-948-00)
ndc11
7120594830
30 TABLET, FILM COATED in 1 BOTTLE (71205-948-30)
ndc11
7120594855
500 TABLET, FILM COATED in 1 BOTTLE (71205-948-55)
ndc11
7120594860
60 TABLET, FILM COATED in 1 BOTTLE (71205-948-60)
ndc11
7120594890
90 TABLET, FILM COATED in 1 BOTTLE (71205-948-90)

Annotations

UNII (FDA Substance ID)

3O2T2PJ89D

DONEPEZIL HYDROCHLORIDE

RxCUI 236559

Orange Book

A203104

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": "71205-948_b974cd85-fbe8-40e4-89a7-b6c6845172e1",
  "productndc": "71205-948",
  "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

Other records sharing ATC code N06DA02.

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