GABITRIL

Product NDC: 63459-416
11-digit product format: 634590416
Labeler code: 63459
Product ID: 63459-416_cdd94737-c30c-4035-8809-78c0ba68b88d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tiagabine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cephalon, LLC
Application: NDA020646
Marketing category: NDA
Marketing start: 2001-04-01
Marketing end: 0000-00-00
Substance: TIAGABINE HYDROCHLORIDE
Active strength: 16 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	63459-416		UNFINISHED	Active or certified unfinished drug listing	2026-08-07
unfinished package	package	63459-416	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	2026-08-07
excluded product	product	63459-416		D	Discontinued by firm	2026-08-07
excluded package	package	63459-416	63459-416-01	D	Discontinued by firm	2026-08-07
excluded package	package	63459-416	63459-416-30	D	Discontinued by firm	2026-08-07

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 2 · 70 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63459-416-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63459-416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63459-416-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63459-416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63459-416-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63459-416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63459-416-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63459-416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63459-416-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63459-416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63459-416-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63459-416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63459-416-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63459-416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63459-416-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63459-416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63459-416-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63459-416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63459-416-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63459-416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63459-416-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63459-416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	63459-416-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63459-416-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63459-416-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020646-001	GABITRIL	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30
N020646-002	GABITRIL	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	RLD	1997-09-30
N020646-003	GABITRIL	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	RLD	1997-09-30
N020646-004	GABITRIL	TIAGABINE HYDROCHLORIDE	20MG	TABLET / ORAL			1997-09-30
N020646-005	GABITRIL	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	RLD	1999-04-16
N020646-006	GABITRIL	TIAGABINE HYDROCHLORIDE	6MG	TABLET / ORAL			2005-11-29
N020646-007	GABITRIL	TIAGABINE HYDROCHLORIDE	8MG	TABLET / ORAL			2005-11-29
N020646-008	GABITRIL	TIAGABINE HYDROCHLORIDE	10MG	TABLET / ORAL			2005-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N020646-001	AB
N020646-002	AB
N020646-003	AB
N020646-005	AB

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 9 · 328 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	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020646-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020646-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020646-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020646-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020646-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020646-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020646-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020646-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020646-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020646-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020646-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020646-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020646-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020646-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020646-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020646-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020646-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020646-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020646-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020646-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020646-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020646-005	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIAGABINE HYDROCHLORIDE	16 mg/1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63459-416-01	EA - Each	63459-416	2410c9dd-ef3c-46a8-a9c6-27ffbea9d6c5	1	2013-02-11
63459-416-30	EA - Each	63459-416	9487995d-f025-4944-bfed-c434acc80a7d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIAGABINE HYDROCHLORIDE	ACTIVE INGREDIENT	DQH6T6D8OY	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
TIAGABINE	ACTIVE MOIETY	Z80I64HMNP	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
HYDROGENATED SOYBEAN OIL	INACTIVE INGREDIENT	A2M91M918C	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CEPHALON, INCORPORATED]	15

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tiagabine Hydrochloride	TIAGABINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	953ef3cc-e3cb-480f-b9ea-256520fd62b8	2021-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020646 application number: NDA020646

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DQH6T6D8OY	TIAGABINE HYDROCHLORIDE	145821-59-6	TIAGABINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63459-416-30	63459041630	30 TABLET, FILM COATED in 1 BOTTLE (63459-416-30)	2010-02-08	0000-00-00	No	No	Current
63459-416-99	63459041699	31115 TABLET, FILM COATED in 1 DRUM (63459-416-99)	08-FEB-10				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GABITRIL ® (tiagabine hydrochloride) Tablets Rx only	Cephalon, LLC	2021-09-30	HUMAN PRESCRIPTION DRUG LABEL	28