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United States · US · US:72578-003_2dee57d8-27d7-481c-b1c9-21375e258a1b
Memantine Hydrochloride
Orange BookUNIISPLATC N06DX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeN06DX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc117257800301100 TABLET in 1 BOTTLE (72578-003-01)
- ndc117257800305500 TABLET in 1 BOTTLE (72578-003-05)
- ndc1172578003101000 TABLET in 1 BOTTLE (72578-003-10)
- ndc11725780031460 TABLET in 1 BOTTLE (72578-003-14)
- ndc11725780037710 BLISTER PACK in 1 CARTON (72578-003-77) / 10 TABLET in 1 BLISTER PACK (72578-003-30)
Annotations
UNII (FDA Substance ID)
JY0WD0UA60
MEMANTINE HYDROCHLORIDE
RxCUI 236685
Orange Book
A090961
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": "72578-003_2dee57d8-27d7-481c-b1c9-21375e258a1b",
"productndc": "72578-003",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090961",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jul 10, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Jul 10, 2017"
}
],
"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": "ANDA090961",
"marketing_category": "ANDA",
"nonproprietary_name": "Memantine Hydrochloride",
"start_marketing_date": "20190228",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N06DX01.
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