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United States · US · US:59651-408_7a208302-90f3-45d0-94fc-9fb38591c543

MEMANTINE HYDROCHLORIDE

Orange BookSPL

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5965140828
    1 BLISTER PACK in 1 CARTON (59651-408-28) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A214651
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "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": "59651-408_7a208302-90f3-45d0-94fc-9fb38591c543",
  "productndc": "59651-408",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "214651",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7MG",
        "product_no": "001",
        "approval_date": "Aug 9, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "14MG",
        "product_no": "002",
        "approval_date": "Aug 9, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "21MG",
        "product_no": "003",
        "approval_date": "Aug 9, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "28MG",
        "product_no": "004",
        "approval_date": "Aug 9, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "MEMANTINE HYDROCHLORIDE",
  "active_ingred_unit": null,
  "application_number": "ANDA214651",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MEMANTINE HYDROCHLORIDE",
  "start_marketing_date": "20210809",
  "active_numerator_strength": null
}

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