SERTRALINE HYDROCHLORIDE

{
  "unii": {
    "unii": "UTI8907Y6X",
    "rxcui": "155137",
    "inchikey": "BLFQGGGGFNSJKA-XHXSRVRCSA-N",
    "display_name": "SERTRALINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6c26a87a-b2b6-4302-bb8d-2031461f28ce": {
      "match": "brand_token",
      "title": "SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-05-28"
    }
  },
  "productid": "71610-433_7c2f1809-97f9-4942-a4f0-5fe016dd709a",
  "productndc": "71610-433",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "019839",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Dec 30, 1991"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Dec 30, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Dec 30, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Dec 30, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "005",
        "approval_date": "Mar 6, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SERTRALINE HYDROCHLORIDE",
  "proprietary_name": "SERTRALINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019839",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "sertraline hydrochloride",
  "start_marketing_date": "20190812",
  "active_numerator_strength": "100"
}