Tiagabine Hydrochloride

{
  "unii": {
    "unii": "DQH6T6D8OY",
    "rxcui": "236875",
    "inchikey": "YUKARLAABCGMCN-PKLMIRHRSA-N",
    "display_name": "TIAGABINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "953ef3cc-e3cb-480f-b9ea-256520fd62b8": {
      "match": "brand_token",
      "title": "TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "18",
      "published_date": "2026-04-15"
    }
  },
  "productid": "0093-8076_2a8d7987-54ae-45d7-8224-361dac37e0a4",
  "productndc": "0093-8076",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020646",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "12MG",
        "product_no": "002",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "16MG",
        "product_no": "003",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "005",
        "approval_date": "Apr 16, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "6MG",
        "product_no": "006",
        "approval_date": "Nov 29, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "8MG",
        "product_no": "007",
        "approval_date": "Nov 29, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "008",
        "approval_date": "Nov 29, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIAGABINE HYDROCHLORIDE",
  "shortage_reason": "Tiagabine Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Tiagabine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020646",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Tiagabine Hydrochloride",
  "start_marketing_date": "20180309",
  "active_numerator_strength": "16"
}