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United States · US · US:50268-588_47e7cea9-cd6c-40d4-e063-6294a90a9e8a
Memantine Hydrochloride
Orange BookUNIISPLATC N06DX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvPAK
CountryUS (United States)
ATC codeN06DX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11502685881330 BLISTER PACK in 1 BOX (50268-588-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-588-11)
Annotations
UNII (FDA Substance ID)
JY0WD0UA60
MEMANTINE HYDROCHLORIDE
RxCUI 236685
Orange Book
A200022
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": "50268-588_47e7cea9-cd6c-40d4-e063-6294a90a9e8a",
"productndc": "50268-588",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "200022",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Oct 13, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Oct 13, 2015"
}
],
"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": "ANDA200022",
"marketing_category": "ANDA",
"nonproprietary_name": "memantine hydrochloride",
"start_marketing_date": "20240220",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06DX01.
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