🇺🇸
United States · US · US:69680-185_ffe5cf41-299a-49e5-a9b8-c9048c4861fa
memantine hydrochloride and donepezil hydrochloride
Orange BookUNIISPLATC N06DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVitruvias Therapeutics, Inc.
CountryUS (United States)
ATC codeN06DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11696801853030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-185-30)
Annotations
UNII (FDA Substance ID)
3O2T2PJ89D
DONEPEZIL HYDROCHLORIDE
RxCUI 236559
Orange Book
A216901
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": {
"afc07196-be28-4521-afc0-d4aa5b6fd46d": {
"match": "brand_token",
"title": "MEMANTINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2026-05-22"
}
},
"productid": "69680-185_ffe5cf41-299a-49e5-a9b8-c9048c4861fa",
"productndc": "69680-185",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "216901",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG;14MG",
"product_no": "001",
"approval_date": "Jul 15, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG;28MG",
"product_no": "002",
"approval_date": "Jul 15, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE",
"proprietary_name": "memantine hydrochloride and donepezil hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA216901",
"marketing_category": "ANDA",
"nonproprietary_name": "memantine hydrochloride and donepezil hydrochloride",
"start_marketing_date": "20250716",
"active_numerator_strength": "10; 28"
}Related drugs
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