donepezil hydrochloride

Orange BookUNIISPLATC N06DA02

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

Identification

ManufacturerUnichem Pharmaceuticals (USA), Inc.

CountryUS (United States)

ATC codeN06DA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
2930024901
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-249-01)
ndc11
2930024910
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-249-10)
ndc11
2930024913
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-249-13)
ndc11
2930024919
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-249-19)

Annotations

UNII (FDA Substance ID)

3O2T2PJ89D

DONEPEZIL HYDROCHLORIDE

RxCUI 236559

Orange Book

A203656

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": "29300-249_88d3f867-45f4-42fb-93f8-235c2f594760",
  "productndc": "29300-249",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203656",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jun 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jun 23, 2016"
      }
    ],
    "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": "ANDA203656",
  "marketing_category": "ANDA",
  "nonproprietary_name": "donepezil hydrochloride",
  "start_marketing_date": "20160623",
  "active_numerator_strength": "10"
}

Related drugs

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