Gabapentin

Product NDC: 50090-5331
Requested package NDC: 50090-5331-2
11-digit product format: 500905331
Labeler code: 50090
Product ID: 50090-5331_0829c6b1-9255-4d03-bdcf-c4d06fcaf7f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA207057
Marketing category: ANDA
Marketing start: 2019-05-01
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 800 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	50090-5331	50090-5331-2	D	Discontinued by firm		2026-08-03

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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207057-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2017-10-26
A207057-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2017-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207057-001	AB1
A207057-002	AB1

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A207057-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207057-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207057-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207057-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207057-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207057-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207057-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207057-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207057-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207057-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207057-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207057-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207057-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207057-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207057-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207057-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207057-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207057-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207057-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207057-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207057-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207057-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207057-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207057-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207057-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207057-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207057-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207057-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207057-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207057-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207057-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207057-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207057-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207057-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207057-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207057-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207057-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207057-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207057-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207057-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-5331-0	2023-02-07	These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50090-5331-1	2023-02-07	These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50090-5331-2	2023-02-07	These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50090-5331-0	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50090-5331-1	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50090-5331-2	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	TAGI Pharma, Inc.	725878fa-1e2f-4fee-a9e1-a6e102c79625	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d8604417-9d43-4d27-a7ce-d4120ff201f4	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	A-S Medication Solutions	b88b0cbc-c883-4d17-8f46-0e5bddc57835	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	A-S Medication Solutions	081fd1de-acaa-4685-a053-4959d77b17e9	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Precision Dose, Inc.	021329d0-7d32-4fd8-81bf-a8b0d8b49e43	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	A-S Medication Solutions	b74a427c-9cc1-4b15-9ed2-cc891741fe67	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Mullan Pharmaceutical Inc.	47a22de2-ec66-45be-8648-89ed3ab6e67e	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Precision Dose, Inc.	86c93d8b-6286-44e2-93dd-f1b10a5d83da	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Proficient Rx LP	87b9171b-7d00-40fa-87ff-a717740efe8a	2025-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Proficient Rx LP	0ad67a07-59d0-4aaa-906b-befbbad8af31	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	07871ab8-254b-e3c2-e063-6294a90a29ab	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	2c65253d-ca49-70eb-e063-6394a90a3cd2	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	AvPAK	faa47fcd-2545-a946-e053-6294a90a05d2	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	ec1a01fe-5531-21df-e053-2a95a90a0561	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	2eec52a1-9016-46dd-8b4c-8dab1d0aeece	2024-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5331-2	50090533102	30 TABLET, COATED in 1 BOTTLE (50090-5331-2)	2020-11-02	0000-00-00	No	No	Current