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United States · US · US:13925-540_cd1fd2cb-7154-4ef6-ac18-e0646a7be6e9
Memantine Hydrochloride
Orange BookUNIISPLATC N06DX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSeton Pharmaceuticals
CountryUS (United States)
ATC codeN06DX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc111392554012360 mL in 1 BOTTLE (13925-540-12)
Annotations
UNII (FDA Substance ID)
JY0WD0UA60
MEMANTINE HYDROCHLORIDE
RxCUI 236685
Orange Book
A210319
AA
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": "13925-540_cd1fd2cb-7154-4ef6-ac18-e0646a7be6e9",
"productndc": "13925-540",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "210319",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "2MG/ML",
"product_no": "001",
"approval_date": "Aug 31, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MEMANTINE HYDROCHLORIDE",
"proprietary_name": "Memantine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA210319",
"marketing_category": "ANDA",
"nonproprietary_name": "Memantine Hydrochloride Oral",
"start_marketing_date": "20200831",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N06DX01.
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