{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "68382-548",
      "generic_name": "Memantine hydrochloride",
      "labeler_name": "Zydus Pharmaceuticals USA Inc.",
      "brand_name": "Memantine hydrochloride",
      "active_ingredients": [
        {
          "name": "MEMANTINE HYDROCHLORIDE",
          "strength": "21 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "68382-548-06",
          "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-548-06)",
          "marketing_start_date": "20180408",
          "sample": false
        },
        {
          "package_ndc": "68382-548-16",
          "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-548-16)",
          "marketing_start_date": "20180408",
          "sample": false
        },
        {
          "package_ndc": "68382-548-77",
          "description": "100 BLISTER PACK in 1 CARTON (68382-548-77)  / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-548-30)",
          "marketing_start_date": "20180408",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "rxcui": [
          "996594",
          "996603",
          "996609",
          "996615"
        ],
        "spl_set_id": [
          "eac265e6-6ea4-4368-acff-2efe6a8dd40a"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368382548061"
        ],
        "unii": [
          "JY0WD0UA60"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "CAPSULE, EXTENDED RELEASE",
      "spl_id": "079cb172-4d62-4571-98b9-5ad01706dbee",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20180408",
      "product_id": "68382-548_079cb172-4d62-4571-98b9-5ad01706dbee",
      "application_number": "ANDA203293",
      "brand_name_base": "Memantine hydrochloride",
      "pharm_class": [
        "N-methyl-D-aspartate Receptor Antagonist [EPC]",
        "NMDA Receptor Antagonists [MoA]"
      ]
    }
  ]
}