Home NDC 72205-084 Tiagabine Hydrochloride
Product NDC 72205-084
11-digit product format 722050084
Labeler code 72205
Product ID 72205-084_7c034fe0-cdac-49e1-8e39-592846ea3bec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tiagabine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA214816
Marketing category ANDA
Marketing start 2021-11-23
Substance TIAGABINE HYDROCHLORIDE
Active strength 2 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214816-001 TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2021-11-16 A214816-002 TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2021-11-16 A214816-003 TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 12MG TABLET / ORAL AB 2021-11-16 A214816-004 TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 16MG TABLET / ORAL AB 2021-11-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A214816-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2021-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214816-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2021-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214816-003 TIAGABINE HYDROCHLORIDE 12MG TABLET / ORAL AB 2021-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214816-004 TIAGABINE HYDROCHLORIDE 16MG TABLET / ORAL AB 2021-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214816-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2021-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214816-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2021-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214816-003 TIAGABINE HYDROCHLORIDE 12MG TABLET / ORAL AB 2021-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214816-004 TIAGABINE HYDROCHLORIDE 16MG TABLET / ORAL AB 2021-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214816-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2021-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214816-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2021-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214816-003 TIAGABINE HYDROCHLORIDE 12MG TABLET / ORAL AB 2021-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214816-004 TIAGABINE HYDROCHLORIDE 16MG TABLET / ORAL AB 2021-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214816-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2021-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214816-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2021-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214816-003 TIAGABINE HYDROCHLORIDE 12MG TABLET / ORAL AB 2021-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214816-004 TIAGABINE HYDROCHLORIDE 16MG TABLET / ORAL AB 2021-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214816-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2021-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214816-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2021-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214816-003 TIAGABINE HYDROCHLORIDE 12MG TABLET / ORAL AB 2021-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214816-004 TIAGABINE HYDROCHLORIDE 16MG TABLET / ORAL AB 2021-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214816-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2021-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214816-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2021-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214816-003 TIAGABINE HYDROCHLORIDE 12MG TABLET / ORAL AB 2021-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214816-004 TIAGABINE HYDROCHLORIDE 16MG TABLET / ORAL AB 2021-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214816-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2021-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214816-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2021-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214816-003 TIAGABINE HYDROCHLORIDE 12MG TABLET / ORAL AB 2021-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214816-004 TIAGABINE HYDROCHLORIDE 16MG TABLET / ORAL AB 2021-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214816-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2021-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214816-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2021-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214816-003 TIAGABINE HYDROCHLORIDE 12MG TABLET / ORAL AB 2021-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214816-004 TIAGABINE HYDROCHLORIDE 16MG TABLET / ORAL AB 2021-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214816-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2021-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214816-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2021-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214816-003 TIAGABINE HYDROCHLORIDE 12MG TABLET / ORAL AB 2021-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214816-004 TIAGABINE HYDROCHLORIDE 16MG TABLET / ORAL AB 2021-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214816-001 TIAGABINE HYDROCHLORIDE 2MG TABLET / ORAL AB 2021-11-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214816-002 TIAGABINE HYDROCHLORIDE 4MG TABLET / ORAL AB 2021-11-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214816-003 TIAGABINE HYDROCHLORIDE 12MG TABLET / ORAL AB 2021-11-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214816-004 TIAGABINE HYDROCHLORIDE 16MG TABLET / ORAL AB 2021-11-16 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tiagabine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIAGABINE HYDROCHLORIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DQH6T6D8OY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1299903 Internal RxNorm lookup 1299909 Internal RxNorm lookup 1299911 Internal RxNorm lookup 1299917 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72205-084-30 Tiagabine Hydrochloride 30 in 1 BOTTLE TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-084 TIAGABINE HYDROCHLORIDE TABLET [NOVADOZ PHARMACEUTICALS LLC] 1 Current NDC, Legacy NDC, 1 package rows 20211124_7c034fe0-cdac-49e1-8e39-592846ea3bec.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72205-084-30 72205008430 30 TABLET in 1 BOTTLE (72205-084-30) 30 tablet 2021-11-23 0000-00-00 No No Current