Memantine and Donepezil Hydrochlorides Extended-release

{
  "unii": {
    "unii": "3O2T2PJ89D",
    "rxcui": "236559",
    "inchikey": "XWAIAVWHZJNZQQ-UHFFFAOYSA-N",
    "display_name": "DONEPEZIL 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": "69238-1553_acd577e1-312c-4d5a-85b5-bc50ef9de545",
  "productndc": "69238-1553",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "208328",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;14MG",
        "product_no": "001",
        "approval_date": "Jan 27, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;28MG",
        "product_no": "002",
        "approval_date": "Jan 27, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;7MG",
        "product_no": "003",
        "approval_date": "Feb 27, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;21MG",
        "product_no": "004",
        "approval_date": "Feb 27, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE",
  "proprietary_name": "Memantine and Donepezil Hydrochlorides Extended-release",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA208328",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Memantine and Donepezil",
  "start_marketing_date": "20170201",
  "active_numerator_strength": "10; 21"
}