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United States · US · US:33342-312_3d9a23dc-8cbe-47c3-a048-70d86cb9dc14
Memantine and Donepezil
Orange BookUNIISPLATC N06DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeN06DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11333423120730 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-07)
- ndc11333423121090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-10)
- ndc11333423121210 BLISTER PACK in 1 CARTON (33342-312-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
3O2T2PJ89D
DONEPEZIL HYDROCHLORIDE
RxCUI 236559
Orange Book
A208672
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": "33342-312_3d9a23dc-8cbe-47c3-a048-70d86cb9dc14",
"productndc": "33342-312",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "208672",
"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 and Donepezil",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA208672",
"marketing_category": "ANDA",
"nonproprietary_name": "Memantine and Donepezil",
"start_marketing_date": "20250715",
"active_numerator_strength": "10; 14"
}Related drugs
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