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United States · US · US:71610-011_f384e3d8-d9fd-481c-b924-4bf98dfb5bdf

memantine hydrochloride

Orange BookUNIISPLATC N06DX01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeN06DX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7161001118
    3000 TABLET in 1 BOTTLE (71610-011-18)

Annotations

UNII (FDA Substance ID)
JY0WD0UA60
MEMANTINE HYDROCHLORIDE
RxCUI 236685
Orange Book
N021487
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": "71610-011_f384e3d8-d9fd-481c-b924-4bf98dfb5bdf",
  "productndc": "71610-011",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021487",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Oct 16, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Oct 16, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEMANTINE HYDROCHLORIDE",
  "proprietary_name": "memantine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021487",
  "marketing_category": "NDA",
  "nonproprietary_name": "memantine hydrochloride",
  "start_marketing_date": "20150401",
  "active_numerator_strength": "10"
}

Related drugs

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