DONEPEZIL HYDROCHLORIDE

Orange BookUNIISPLATC N06DA02

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

Identification

ManufacturerCadila Pharmaceuticals Limited

CountryUS (United States)

ATC codeN06DA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7120902001
30 TABLET, FILM COATED in 1 BOTTLE (71209-020-01)
ndc11
7120902004
90 TABLET, FILM COATED in 1 BOTTLE (71209-020-04)
ndc11
7120902011
1000 TABLET, FILM COATED in 1 BOTTLE (71209-020-11)

Annotations

UNII (FDA Substance ID)

3O2T2PJ89D

DONEPEZIL HYDROCHLORIDE

RxCUI 236559

Orange Book

A204609

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": "71209-020_e33aac76-604d-43cb-8be4-d58ce3b2b6f8",
  "productndc": "71209-020",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204609",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Sep 19, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Sep 19, 2017"
      }
    ],
    "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": "ANDA204609",
  "marketing_category": "ANDA",
  "nonproprietary_name": "donepezil hydrochloride",
  "start_marketing_date": "20170130",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06DA02.

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