memantine hydrochloride

Orange BookSPL

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

Identification

ManufacturerActavis Pharma, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0591390087
1 BLISTER PACK in 1 CARTON (0591-3900-87) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

N021487

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "0591-3900_985e1190-b8a0-4775-9a20-ad1924b14fb2",
  "productndc": "0591-3900",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "memantine hydrochloride",
  "active_ingred_unit": null,
  "application_number": "NDA021487",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "memantine hydrochloride",
  "start_marketing_date": "20150401",
  "active_numerator_strength": null
}

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