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United States · US · US:65162-783_fb7782a5-2357-4a21-86a6-0eeaa7cdcea5
Memantine Hydrochloride
Orange BookUNIISPLATC N06DX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN06DX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11651627830330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-03)
- ndc11651627830990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-09)
- ndc116516278350500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-783-50)
Annotations
UNII (FDA Substance ID)
JY0WD0UA60
MEMANTINE HYDROCHLORIDE
RxCUI 236685
Orange Book
A205825
ABABABAB
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": "65162-783_fb7782a5-2357-4a21-86a6-0eeaa7cdcea5",
"productndc": "65162-783",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "205825",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7MG",
"product_no": "001",
"approval_date": "Oct 12, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "14MG",
"product_no": "002",
"approval_date": "Oct 12, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "21MG",
"product_no": "003",
"approval_date": "Oct 12, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "28MG",
"product_no": "004",
"approval_date": "Oct 12, 2016"
}
],
"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": "ANDA205825",
"marketing_category": "ANDA",
"nonproprietary_name": "Memantine Hydrochloride",
"start_marketing_date": "20171222",
"active_numerator_strength": "14"
}Related drugs
Other records sharing ATC code N06DX01.
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