tiagabine hydrochloride

Generic: tiagabine hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tiagabine hydrochloride
Generic Name tiagabine hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tiagabine hydrochloride 4 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-224
Product ID 62756-224_57975e74-e45b-4fd9-9718-bfc9690acae5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077555
Listing Expiration 2026-12-31
Marketing Start 2011-11-04

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 62756224
Hyphenated Format 62756-224

Supplemental Identifiers

RxCUI
1299911 1299917
UPC
0362756200838 0362756224834
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 ANDA077555 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (62756-224-08)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62756-224-18)
  • 30 TABLET, FILM COATED in 1 BOTTLE (62756-224-83)
  • 100 TABLET, FILM COATED in 1 BOTTLE (62756-224-88)
source: ndc

Packages (4)

62756-224-08 100 TABLET, FILM COATED in 1 BOTTLE (62756-224-08) 62756-224-18 1000 TABLET, FILM COATED in 1 BOTTLE (62756-224-18) 62756-224-83 30 TABLET, FILM COATED in 1 BOTTLE (62756-224-83) 62756-224-88 100 TABLET, FILM COATED in 1 BOTTLE (62756-224-88)

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": "57975e74-e45b-4fd9-9718-bfc9690acae5", "openfda": {"upc": ["0362756200838", "0362756224834"], "unii": ["DQH6T6D8OY"], "rxcui": ["1299911", "1299917"], "spl_set_id": ["7eeb2d81-c5d7-46a0-aa5c-149b55df71bd"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (62756-224-08)", "package_ndc": "62756-224-08", "marketing_start_date": "20111104"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62756-224-18)", "package_ndc": "62756-224-18", "marketing_start_date": "20111104"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62756-224-83)", "package_ndc": "62756-224-83", "marketing_start_date": "20111104"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (62756-224-88)", "package_ndc": "62756-224-88", "marketing_start_date": "20111104"}], "brand_name": "TIAGABINE HYDROCHLORIDE", "product_id": "62756-224_57975e74-e45b-4fd9-9718-bfc9690acae5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "62756-224", "generic_name": "TIAGABINE HYDROCHLORIDE", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TIAGABINE HYDROCHLORIDE", "active_ingredients": [{"name": "TIAGABINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA077555", "marketing_category": "ANDA", "marketing_start_date": "20111104", "listing_expiration_date": "20261231"}