GABITRIL

Product NDC: 68151-4235
11-digit product format: 681514235
Labeler code: 68151
Product ID: 68151-4235_7c25748c-ffc7-452a-999a-414101b232d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tiagabine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Carilion Materials Management
Application: NDA020646
Marketing category: NDA
Marketing start: 2001-04-01
Marketing end: 0000-00-00
Substance: TIAGABINE HYDROCHLORIDE
Active strength: 4 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68151-4235		I	Inactivated by FDA		2026-08-07
excluded package	package	68151-4235	68151-4235-3	I	Inactivated by FDA		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 1 · 44 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	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68151-4235-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68151-4235-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68151-4235-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68151-4235-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68151-4235-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68151-4235-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68151-4235-3	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68151-4235-3	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68151-4235-3	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68151-4235-3	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68151-4235-3	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68151-4235-3	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68151-4235-3	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68151-4235-3	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68151-4235-3	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68151-4235-3	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68151-4235-3	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68151-4235-3	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68151-4235-3	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68151-4235-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68151-4235-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68151-4235-3	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b72e14f-1cc2-c389-aef5-c9c0a7b93fb8	Product name	4	20220613
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-4235-3	2020-01-31	C162847	48780-1	9d75b9d0-fcfd-f424-e053-dadaa90a57ce	GABITRIL ® (tiagabine hydrochloride) Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-4235-3	GABITRIL	1 in 1 PACKAGE	TABLET, FILM COATED	1		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIAGABINE HYDROCHLORIDE	ACTIVE INGREDIENT	DQH6T6D8OY	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
tiagabine	ACTIVE MOIETY	Z80I64HMNP	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-4235	GABITRIL (TIAGABINE HYDROCHLORIDE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3	Legacy NDC, 1 package rows	20160808_72b7f357-8827-4a8b-b55a-01fbce47ae80.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.

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1299978	Gabitril 4 MG Oral Tablet	PSN	72b7f357-8827-4a8b-b55a-01fbce47ae80	3
1299917	tiaGABine HCl 4 MG Oral Tablet	PSN	72b7f357-8827-4a8b-b55a-01fbce47ae80	3
1299978	tiagabine hydrochloride 4 MG Oral Tablet [Gabitril]	SBD	72b7f357-8827-4a8b-b55a-01fbce47ae80	3
1299917	tiagabine hydrochloride 4 MG Oral Tablet	SCD	72b7f357-8827-4a8b-b55a-01fbce47ae80	3
1299978	Gabitril 4 MG Oral Tablet	SY	72b7f357-8827-4a8b-b55a-01fbce47ae80	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-4235-3	68151423503	1 in 1 PACKAGE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GABITRIL ® (tiagabine hydrochloride) Tablets Rx only	Carilion Materials Management	2016-08-06	HUMAN PRESCRIPTION DRUG LABEL	3