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United States · US · US:42799-954_19147d81-49ac-463e-8643-26dace803ea5
Donepezil hydrochloride
Orange BookUNIISPLATC N06DA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEdenbridge Pharmaceuticals LLC.
CountryUS (United States)
ATC codeN06DA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11427999540130 TABLET, FILM COATED in 1 BOTTLE (42799-954-01)
- ndc11427999540290 TABLET, FILM COATED in 1 BOTTLE (42799-954-02)
Annotations
UNII (FDA Substance ID)
3O2T2PJ89D
DONEPEZIL HYDROCHLORIDE
RxCUI 236559
Orange Book
A203713
AB
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": "42799-954_19147d81-49ac-463e-8643-26dace803ea5",
"productndc": "42799-954",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203713",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "23MG",
"product_no": "001",
"approval_date": "Feb 19, 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": "ANDA203713",
"marketing_category": "ANDA",
"nonproprietary_name": "Donepezil hydrochloride",
"start_marketing_date": "20160219",
"active_numerator_strength": "23"
}Related drugs
Other records sharing ATC code N06DA02.
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- CAAG-DONEPEZILANGITA PHARMA INC.
- CAAG-DONEPEZILANGITA PHARMA INC.
- CZALZILGlenmark Pharmaceuticals s.r.o., Praha
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- CZALZILGlenmark Pharmaceuticals s.r.o., Praha
- CZALZILGlenmark Pharmaceuticals s.r.o., Praha
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