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United States · US · US:0093-5031_2a8d7987-54ae-45d7-8224-361dac37e0a4
Tiagabine Hydrochloride
In shortageOrange BookUNIISPLATC N03AG06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeN03AG06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11009350315630 TABLET, FILM COATED in 1 BOTTLE (0093-5031-56)
Annotations
UNII (FDA Substance ID)
DQH6T6D8OY
TIAGABINE HYDROCHLORIDE
RxCUI 236875
Orange Book
N020646
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": "0093-5031_2a8d7987-54ae-45d7-8224-361dac37e0a4",
"productndc": "0093-5031",
"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": "20160603",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code N03AG06.
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