Tiagabine Hydrochloride

Product NDC: 69238-1104
Requested package NDC: 69238-1104-3
11-digit product format: 692381104
Labeler code: 69238
Product ID: 69238-1104_012eca85-d949-4fd3-863e-1fac922150b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tiagabine
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA208181
Marketing category: ANDA
Marketing start: 2017-12-08
Marketing end: 0000-00-00
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69238-1104	69238-1104-3	D	Discontinued by firm		2026-08-07

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	Approval date
A208181-001	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	2017-12-08
A208181-002	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	2017-12-08
A208181-003	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	2017-12-08
A208181-004	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	2017-12-08

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208181-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	2017-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208181-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	2017-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208181-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	2017-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208181-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	2017-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208181-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	2017-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208181-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	2017-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208181-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	2017-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208181-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	2017-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208181-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	2017-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208181-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	2017-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208181-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	2017-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208181-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	2017-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208181-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	2017-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208181-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	2017-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208181-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	2017-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208181-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	2017-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208181-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	2017-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208181-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	2017-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208181-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	2017-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208181-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	2017-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208181-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	2017-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208181-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	2017-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208181-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	2017-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208181-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	2017-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208181-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	2017-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208181-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	2017-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208181-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	2017-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208181-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	2017-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208181-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	2017-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208181-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	2017-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208181-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	2017-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208181-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	2017-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208181-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	2017-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208181-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	2017-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208181-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	2017-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208181-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	2017-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208181-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	2017-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208181-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	2017-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208181-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	2017-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208181-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	2017-12-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208181-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208181-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208181-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208181-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208181-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208181-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208181-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208181-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208181-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208181-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208181-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208181-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208181-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208181-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208181-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208181-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208181-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208181-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208181-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208181-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208181-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208181-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208181-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208181-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208181-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208181-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208181-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208181-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208181-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208181-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208181-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208181-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208181-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208181-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208181-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208181-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208181-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208181-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208181-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208181-004	AB	1	`c0c555d07b60…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1104-3	EA - Each	69238-1104	0f8eff13-0555-4a9f-b78d-3fd52c9861fc	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1104	TIAGABINE HYDROCHLORIDE (TIAGABINE) TABLET [AMNEAL PHARMACEUTICALS NY LLC]	7	Legacy NDC	20240102_7036c6df-6527-4701-b484-6b962914b52a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DQH6T6D8OY	TIAGABINE HYDROCHLORIDE	145821-59-6	TIAGABINE HYDROCHLORIDE
Z80I64HMNP	TIAGABINE	115103-54-3	Tiagabine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1104-3	69238110403	30 TABLET in 1 BOTTLE (69238-1104-3)	30 tablet	2017-12-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tiagabine Hydrochloride Tablets	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals Private Limited	2023-12-30	HUMAN PRESCRIPTION DRUG LABEL	7