tiagabine hydrochloride

Generic: tiagabine hydrochloride

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tiagabine hydrochloride
Generic Name tiagabine hydrochloride
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tiagabine hydrochloride 16 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-087
Product ID 72205-087_7c034fe0-cdac-49e1-8e39-592846ea3bec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214816
Listing Expiration 2026-12-31
Marketing Start 2021-11-23

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 72205087
Hyphenated Format 72205-087

Supplemental Identifiers

RxCUI
1299903 1299909 1299911 1299917
UPC
0372205086302 0372205087309 0372205085305 0372205084308
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 ANDA214816 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 16 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72205-087-30)
source: ndc

Packages (1)

72205-087-30 30 TABLET in 1 BOTTLE (72205-087-30)

Ingredients (1)

tiagabine hydrochloride (16 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": "7c034fe0-cdac-49e1-8e39-592846ea3bec", "openfda": {"upc": ["0372205086302", "0372205087309", "0372205085305", "0372205084308"], "unii": ["DQH6T6D8OY"], "rxcui": ["1299903", "1299909", "1299911", "1299917"], "spl_set_id": ["7c034fe0-cdac-49e1-8e39-592846ea3bec"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72205-087-30)", "package_ndc": "72205-087-30", "marketing_start_date": "20211123"}], "brand_name": "Tiagabine Hydrochloride", "product_id": "72205-087_7c034fe0-cdac-49e1-8e39-592846ea3bec", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72205-087", "generic_name": "Tiagabine Hydrochloride", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tiagabine Hydrochloride", "active_ingredients": [{"name": "TIAGABINE HYDROCHLORIDE", "strength": "16 mg/1"}], "application_number": "ANDA214816", "marketing_category": "ANDA", "marketing_start_date": "20211123", "listing_expiration_date": "20261231"}