PAXIL

{
  "unii": {
    "unii": "X2ELS050D8",
    "rxcui": "1298842",
    "inchikey": "MQZOATSIFWSKKT-OASXIEIISA-N",
    "display_name": "PAROXETINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "483bd97f-c4d0-4e23-aaa8-6334f4471e0c": {
      "match": "brand_token",
      "title": "PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]",
      "spl_version": "32",
      "published_date": "2025-09-25"
    }
  },
  "productid": "60505-4377_57998b73-87c9-7fed-ffa8-7e43620bd98a",
  "productndc": "60505-4377",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020936",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 12.5MG BASE",
        "product_no": "001",
        "approval_date": "Feb 16, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Feb 16, 1999"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "003",
        "approval_date": "Dec 6, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE HYDROCHLORIDE",
  "proprietary_name": "PAXIL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020936",
  "marketing_category": "NDA",
  "nonproprietary_name": "paroxetine hydrochloride",
  "start_marketing_date": "20110101",
  "active_numerator_strength": "12.5"
}