Donepezil Hydrochloride

Orange BookUNIISPLATC N06DA02

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeN06DA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
3334202807
30 TABLET, FILM COATED in 1 BOTTLE (33342-028-07)
ndc11
3334202810
90 TABLET, FILM COATED in 1 BOTTLE (33342-028-10)
ndc11
3334202812
10 BLISTER PACK in 1 CARTON (33342-028-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
3334202815
500 TABLET, FILM COATED in 1 BOTTLE (33342-028-15)
ndc11
3334202831
5 BLISTER PACK in 1 CARTON (33342-028-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
3334202844
1000 TABLET, FILM COATED in 1 BOTTLE (33342-028-44)

Annotations

UNII (FDA Substance ID)

3O2T2PJ89D

DONEPEZIL HYDROCHLORIDE

RxCUI 236559

Orange Book

A201146

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": "33342-028_4bf742a3-3c8f-4bd3-b973-54370cbef345",
  "productndc": "33342-028",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "201146",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Aug 17, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Aug 17, 2012"
      }
    ],
    "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": "ANDA201146",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Donepezil Hydrochloride",
  "start_marketing_date": "20120817",
  "active_numerator_strength": "10"
}

Related drugs

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