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United States · US · US:52605-071_4fe4f372-10c2-42ca-bc69-d78a489672b2
memantine hydrochloride
Orange BookUNIISPLATC N06DX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPOLYGEN PHARMACEUTICALS INC.
CountryUS (United States)
ATC codeN06DX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1152605071101000 TABLET, FILM COATED in 1 BOTTLE (52605-071-10)
- ndc11526050711330 TABLET, FILM COATED in 1 BOTTLE (52605-071-13)
- ndc11526050711660 TABLET, FILM COATED in 1 BOTTLE (52605-071-16)
Annotations
UNII (FDA Substance ID)
JY0WD0UA60
MEMANTINE HYDROCHLORIDE
RxCUI 236685
Orange Book
A210587
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "JY0WD0UA60",
"rxcui": "236685",
"inchikey": "LDDHMLJTFXJGPI-UHFFFAOYSA-N",
"display_name": "MEMANTINE 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": "52605-071_4fe4f372-10c2-42ca-bc69-d78a489672b2",
"productndc": "52605-071",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210587",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Dec 11, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Dec 11, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MEMANTINE HYDROCHLORIDE",
"proprietary_name": "memantine hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210587",
"marketing_category": "ANDA",
"nonproprietary_name": "memantine hydrochloride",
"start_marketing_date": "20210701",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N06DX01.
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