Home NDC 16714-153-01 Tiagabine Hydrochloride
Product NDC 16714-153
Requested package NDC 16714-153-01
11-digit product format 167140153
Labeler code 16714
Product ID 16714-153_03a5672d-d01c-495c-91d9-d1f4e8426093
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tiagabine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Northstar Rx LLC
Application ANDA214816
Marketing category ANDA
Marketing start 2021-11-24
Marketing end 0000-00-00
Substance TIAGABINE HYDROCHLORIDE
Active strength 12 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16714-153-01 16714015301 30 TABLET in 1 BOTTLE (16714-153-01) 30 tablet 2021-11-24 0000-00-00 No No Current