AMITRIPTYLINE HYDROCHLORIDE

{
  "unii": {
    "unii": "26LUD4JO9K",
    "rxcui": "203168",
    "inchikey": "KFYRPLNVJVHZGT-UHFFFAOYSA-N",
    "display_name": "AMITRIPTYLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ce87013b-bf4a-47d1-9808-7cb8290feb23": {
      "match": "brand_token",
      "title": "AMITRIPTYLINE HYDROCHLORIDE TABLET, COATED [REMEDYREPACK INC.]",
      "spl_version": "5",
      "published_date": "2026-05-04"
    }
  },
  "productid": "63187-637_503fd66a-220b-410b-b82f-2c449dbb8dab",
  "productndc": "63187-637",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202446",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 4, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Jun 4, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Jun 4, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Jun 4, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Jun 4, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "006",
        "approval_date": "Jun 4, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMITRIPTYLINE HYDROCHLORIDE",
  "proprietary_name": "AMITRIPTYLINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202446",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMITRIPTYLINE HYDROCHLORIDE",
  "start_marketing_date": "20141205",
  "active_numerator_strength": "10"
}