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United States · US · US:62756-224_57975e74-e45b-4fd9-9718-bfc9690acae5

TIAGABINE HYDROCHLORIDE

In shortageOrange BookUNIISPLATC N03AG06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN03AG06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6275622408
    100 TABLET, FILM COATED in 1 BOTTLE (62756-224-08)
  • ndc11
    6275622418
    1000 TABLET, FILM COATED in 1 BOTTLE (62756-224-18)
  • ndc11
    6275622483
    30 TABLET, FILM COATED in 1 BOTTLE (62756-224-83)
  • ndc11
    6275622488
    100 TABLET, FILM COATED in 1 BOTTLE (62756-224-88)

Annotations

UNII (FDA Substance ID)
DQH6T6D8OY
TIAGABINE HYDROCHLORIDE
RxCUI 236875
Orange Book
A077555
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": "62756-224_57975e74-e45b-4fd9-9718-bfc9690acae5",
  "productndc": "62756-224",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077555",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Nov 4, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "Nov 4, 2011"
      }
    ],
    "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": "ANDA077555",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TIAGABINE HYDROCHLORIDE",
  "start_marketing_date": "20111104",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N03AG06.

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