Tiagabine Hydrochloride

In shortageOrange BookUNIISPLATC N03AG06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNovadoz Pharmaceuticals LLC

CountryUS (United States)

ATC codeN03AG06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7220508530
30 TABLET in 1 BOTTLE (72205-085-30)

Annotations

UNII (FDA Substance ID)

DQH6T6D8OY

TIAGABINE HYDROCHLORIDE

RxCUI 236875

Orange Book

A214816

ABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Tiagabine Hydrochloride Tablet

Raw payload (JSON)

{
  "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": "72205-085_7c034fe0-cdac-49e1-8e39-592846ea3bec",
  "productndc": "72205-085",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214816",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Nov 16, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "Nov 16, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12MG",
        "product_no": "003",
        "approval_date": "Nov 16, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "16MG",
        "product_no": "004",
        "approval_date": "Nov 16, 2021"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA214816",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tiagabine Hydrochloride",
  "start_marketing_date": "20211123",
  "active_numerator_strength": "4"
}

Related drugs

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