tiagabine hydrochloride

Generic: tiagabine hydrochloride

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tiagabine hydrochloride
Generic Name tiagabine hydrochloride
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tiagabine hydrochloride 4 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-5031
Product ID 0093-5031_6e4d6688-2ad2-4a19-a244-c08330649039
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020646
Listing Expiration 2026-12-31
Marketing Start 2016-06-03

Pharmacologic Class

Classes
anti-epileptic agent [epc] decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00935031
Hyphenated Format 0093-5031

Supplemental Identifiers

RxCUI
1299903 1299909 1299911 1299917
UNII
DQH6T6D8OY

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tiagabine hydrochloride (source: ndc)
Generic Name tiagabine hydrochloride (source: ndc)
Application Number NDA020646 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0093-5031-56)
source: ndc

Packages (1)

0093-5031-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-5031-56)

Ingredients (1)

tiagabine hydrochloride (4 mg/1)

Linked Drug Pages (1)

Tiagabine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6e4d6688-2ad2-4a19-a244-c08330649039", "openfda": {"unii": ["DQH6T6D8OY"], "rxcui": ["1299903", "1299909", "1299911", "1299917"], "spl_set_id": ["953ef3cc-e3cb-480f-b9ea-256520fd62b8"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0093-5031-56)", "package_ndc": "0093-5031-56", "marketing_start_date": "20160718"}], "brand_name": "Tiagabine Hydrochloride", "product_id": "0093-5031_6e4d6688-2ad2-4a19-a244-c08330649039", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0093-5031", "generic_name": "Tiagabine Hydrochloride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tiagabine Hydrochloride", "active_ingredients": [{"name": "TIAGABINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "NDA020646", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20160603", "listing_expiration_date": "20261231"}