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United States · US · US:62559-207_cd8d0e95-24ac-43e1-9d43-bb081b4f341e
MEMANTINE AND DONEPEZIL HYDROCHLORIDES
Orange BookUNIISPLATC N06DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11625592073030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-207-30)
Annotations
UNII (FDA Substance ID)
3O2T2PJ89D
DONEPEZIL HYDROCHLORIDE
RxCUI 236559
Orange Book
A208237
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": {
"afc07196-be28-4521-afc0-d4aa5b6fd46d": {
"match": "brand_token",
"title": "MEMANTINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2026-05-22"
}
},
"productid": "62559-207_cd8d0e95-24ac-43e1-9d43-bb081b4f341e",
"productndc": "62559-207",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "208237",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG;21MG",
"product_no": "001",
"approval_date": "Dec 15, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE",
"proprietary_name": "MEMANTINE AND DONEPEZIL HYDROCHLORIDES",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA208237",
"marketing_category": "ANDA",
"nonproprietary_name": "MEMANTINE AND DONEPEZIL HYDROCHLORIDES",
"start_marketing_date": "20250101",
"active_numerator_strength": "10; 21"
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