Memantine hydrochloride

Orange BookUNIISPLATC N06DX01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeN06DX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
3334222107
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-221-07)
ndc11
3334222112
10 BLISTER PACK in 1 CARTON (33342-221-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

JY0WD0UA60

MEMANTINE HYDROCHLORIDE

RxCUI 236685

Orange Book

A206310

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": "33342-221_1c695653-b7dd-40af-b5eb-a6e3ecbab14d",
  "productndc": "33342-221",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "206310",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7MG",
        "product_no": "001",
        "approval_date": "Aug 28, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "14MG",
        "product_no": "002",
        "approval_date": "Aug 28, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "21MG",
        "product_no": "003",
        "approval_date": "Aug 28, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "28MG",
        "product_no": "004",
        "approval_date": "Aug 28, 2025"
      }
    ],
    "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": "ANDA206310",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Memantine hydrochloride",
  "start_marketing_date": "20250828",
  "active_numerator_strength": "21"
}

Related drugs

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