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United States · US · US:47335-322_81ca8cbf-7854-43a2-bd0b-1dbaf4709a42
Memantine Hydrochloride
Orange BookUNIISPLATC N06DX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN06DX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc114733532208100 TABLET, FILM COATED in 1 BOTTLE (47335-322-08)
- ndc114733532213500 TABLET, FILM COATED in 1 BOTTLE (47335-322-13)
- ndc1147335322181000 TABLET, FILM COATED in 1 BOTTLE (47335-322-18)
- ndc11473353228330 TABLET, FILM COATED in 1 BOTTLE (47335-322-83)
- ndc11473353228660 TABLET, FILM COATED in 1 BOTTLE (47335-322-86)
- ndc114733532288100 TABLET, FILM COATED in 1 BOTTLE (47335-322-88)
Annotations
UNII (FDA Substance ID)
JY0WD0UA60
MEMANTINE HYDROCHLORIDE
RxCUI 236685
Orange Book
A090058
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": "47335-322_81ca8cbf-7854-43a2-bd0b-1dbaf4709a42",
"productndc": "47335-322",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090058",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "May 5, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "May 5, 2010"
}
],
"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": "ANDA090058",
"marketing_category": "ANDA",
"nonproprietary_name": "Memantine Hydrochloride",
"start_marketing_date": "20150711",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06DX01.
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