Vigabatrin

Product NDC: 0591-3851
Requested package NDC: 0591-3851-77
11-digit product format: 005913851
Labeler code: 0591
Product ID: 0591-3851_c29a7450-ee68-466a-a33f-bf5065da1593
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vigabatrin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA209822
Marketing category: ANDA
Marketing start: 2019-02-06
Substance: VIGABATRIN
Active strength: 500 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
unfinished package	package	0591-3851	0591-3851-77	UNFINISHED	Active or certified unfinished drug listing		2026-08-17

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 · 11 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209822-001	VIGABATRIN	VIGABATRIN	500MG	TABLET / ORAL	AB		2019-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209822-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209822-001	VIGABATRIN	500MG	TABLET / ORAL	AB	2019-01-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209822-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209822-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209822-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209822-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209822-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209822-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209822-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209822-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209822-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209822-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209822-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209822-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209822-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209822-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209822-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209822-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209822-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209822-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209822-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209822-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209822-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209822-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209822-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209822-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209822-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209822-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209822-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209822-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209822-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209822-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209822-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209822-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209822-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209822-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209822-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209822-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209822-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209822-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209822-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209822-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Vigabatrin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VIGABATRIN	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GR120KRT6K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199521	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
8dc7bd15-2636-4d58-b651-dd117ca43dbd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
096748f0-965a-4afd-a326-9f691a2861e8	Product name	1	20250224
9dea3de0-6f03-9477-9f83-4ffb0883e43f	Product name	6	20240507
9a8c6108-e754-40ae-a629-36a466ae0079	Product name	8	20230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-3851-01	Vigabatrin	100 in 1 BOTTLE	TABLET, FILM COATED	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3851-01	EA - Each	0591-3851	5e6e1def-bc8a-434e-a817-ad4f0b26e206	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-3851	VIGABATRIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	13	Current NDC, Legacy NDC, 1 package rows	20250507_8dc7bd15-2636-4d58-b651-dd117ca43dbd.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
Vigabatrin	VIGABATRIN	Actavis Pharma, Inc.	8dc7bd15-2636-4d58-b651-dd117ca43dbd	2024-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209822 application number: ANDA209822 ndc (product): 0591-3851

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GR120KRT6K	VIGABATRIN	68506-86-5	VIGABATRIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199521	vigabatrin 500 MG Oral Tablet	PSN	8dc7bd15-2636-4d58-b651-dd117ca43dbd	13
199521	vigabatrin 500 MG Oral Tablet	SCD	8dc7bd15-2636-4d58-b651-dd117ca43dbd	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Status
0591-3851-77	00591385177	16956 TABLET, FILM COATED in 1 CONTAINER (0591-3851-77)	22-AUG-24	31-MAY-27	Historical