Tiagabine Hydrochloride

Product NDC: 0093-5030
11-digit product format: 000935030
Labeler code: 0093
Product ID: 0093-5030_2a8d7987-54ae-45d7-8224-361dac37e0a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tiagabine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: NDA020646
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-06-03
Marketing end: 2026-10-31
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
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 · 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: Yes
Brand name base: Tiagabine Hydrochloride

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
953ef3cc-e3cb-480f-b9ea-256520fd62b8	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-5030-56	Tiagabine Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-5030-56	EA - Each	0093-5030	5a1cdca2-80e8-493d-9fde-f7bd5b3b38df	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-5030	TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	16	Current NDC, Legacy NDC, 1 package rows	20240828_953ef3cc-e3cb-480f-b9ea-256520fd62b8.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 ndc (product): 0093-5030

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
1299903	tiaGABine HCl 12 MG Oral Tablet	PSN	953ef3cc-e3cb-480f-b9ea-256520fd62b8	18
1299909	tiaGABine HCl 16 MG Oral Tablet	PSN	953ef3cc-e3cb-480f-b9ea-256520fd62b8	18
1299911	tiaGABine HCl 2 MG Oral Tablet	PSN	953ef3cc-e3cb-480f-b9ea-256520fd62b8	18
1299917	tiaGABine HCl 4 MG Oral Tablet	PSN	953ef3cc-e3cb-480f-b9ea-256520fd62b8	18
1299903	tiagabine hydrochloride 12 MG Oral Tablet	SCD	953ef3cc-e3cb-480f-b9ea-256520fd62b8	18
1299909	tiagabine hydrochloride 16 MG Oral Tablet	SCD	953ef3cc-e3cb-480f-b9ea-256520fd62b8	18
1299911	tiagabine hydrochloride 2 MG Oral Tablet	SCD	953ef3cc-e3cb-480f-b9ea-256520fd62b8	18
1299917	tiagabine hydrochloride 4 MG Oral Tablet	SCD	953ef3cc-e3cb-480f-b9ea-256520fd62b8	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-5030-56	00093503056	30 TABLET, FILM COATED in 1 BOTTLE (0093-5030-56)	2016-06-03	2026-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tiagabine Hydrochloride Tablets Rx only	Teva Pharmaceuticals USA, Inc.	2021-09-30	HUMAN PRESCRIPTION DRUG LABEL	18