Gabapentin

Product NDC: 51407-047
11-digit product format: 514070047
Labeler code: 51407
Product ID: 51407-047_e808aa6f-9f78-285b-e053-2a95a90a2b21
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA204989
Marketing category: ANDA
Marketing start: 2016-02-18
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 100 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51407-047		D	Discontinued by firm	2026-10-05
excluded package	package	51407-047	51407-047-10	D	Discontinued by firm	2026-10-05
excluded package	package	51407-047	51407-047-18	D	Discontinued by firm	2026-10-05
excluded package	package	51407-047	51407-047-27	D	Discontinued by firm	2026-10-05
excluded package	package	51407-047	51407-047-90	D	Discontinued by firm	2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	TE codes	Approval date
A204989-001	RELGAABI	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18
A204989-002	RELGAABI	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18
A204989-003	RELGAABI	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18
A204989-004	RELGAABI	GABAPENTIN	200MG	CAPSULE / ORAL	AB	2026-03-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A204989-001	AB
A204989-002	AB
A204989-003	AB
A204989-004	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 4 · 132 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
2026-09-14 22:38:34	2026-08	A204989-001	RELGAABI	100MG	CAPSULE / ORAL	AB	2016-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204989-002	RELGAABI	300MG	CAPSULE / ORAL	AB	2016-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204989-003	RELGAABI	400MG	CAPSULE / ORAL	AB	2016-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204989-004	RELGAABI	200MG	CAPSULE / ORAL	AB	2026-03-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204989-001	RELGAABI	100MG	CAPSULE / ORAL	AB	2016-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204989-002	RELGAABI	300MG	CAPSULE / ORAL	AB	2016-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204989-003	RELGAABI	400MG	CAPSULE / ORAL	AB	2016-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204989-004	RELGAABI	200MG	CAPSULE / ORAL	AB	2026-03-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204989-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204989-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204989-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204989-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204989-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204989-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204989-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204989-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204989-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204989-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204989-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204989-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204989-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204989-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204989-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204989-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204989-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204989-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204989-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204989-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204989-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204989-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204989-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204989-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204989-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204989-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204989-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204989-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204989-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204989-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204989-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204989-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204989-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204989-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204989-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204989-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204989-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204989-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204989-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204989-002	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cdc2ae60-922e-452d-a42f-787fe4e2ed06	Product name	1	20250123
7059096a-4b9f-36c2-db50-bb5c723e6e9e	Product name	2	20250114
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51407-047-10	Gabapentin	1000 in 1 BOTTLE, PLASTIC	CAPSULE	1000	11
51407-047-18	Gabapentin	180 in 1 BOTTLE, PLASTIC	CAPSULE	180	11
51407-047-27	Gabapentin	270 in 1 BOTTLE, PLASTIC	CAPSULE	270	11
51407-047-90	Gabapentin	90 in 1 BOTTLE, PLASTIC	CAPSULE	90	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-047-10	EA - Each	51407-047	72dc3699-123f-4233-990d-9c0206bcb3a3	1	2018-11-06
51407-047-18	EA - Each	51407-047	5f6c93be-0145-4cd7-ae44-7090db73a71c	1	2018-11-06
51407-047-27	EA - Each	51407-047	814dc6a6-c6fb-4de4-b604-1890938482ca	1	2018-11-06
51407-047-90	EA - Each	51407-047	74fa51d1-baa1-42aa-b2d4-46604d496cf0	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-047	GABAPENTIN CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	9	Legacy NDC, 4 package rows	20231227_76f5eff8-698f-2753-e053-2991aa0ae7f9.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 3 of 3 · 54 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Quality Care Products, LLC	ed3a0d48-2e98-44ee-8743-880d1221a480	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Proficient Rx LP	481e6b68-50e4-4594-9815-32580a84ab8c	2024-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	2f70c496-b58c-30f5-e054-00144ff8d46c	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Creekwood Pharmaceuticals LLC	26aac429-a5cd-33cc-e063-6394a90aecc0	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Medsource Pharmaceuticals	12f0c2ee-9a44-9778-e063-6294a90a3b58	2024-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Proficient Rx LP	1749d731-bc8c-4374-b2a9-7c809c457f56	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Proficient Rx LP	22f2294f-352a-4515-87c8-a6ae46e61322	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Proficient Rx LP	f7a943ec-9a13-45ba-9bc5-18162b86b921	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	20e48004-d8b6-40fd-929b-b95087b4d85d	2022-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	88ac51c4-5fa9-4c35-9c63-f26bcb101d4b	2022-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Proficient Rx LP	ed22b78e-93ff-4cb5-9c9c-2afe9b60dd2e	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Proficient Rx LP	223a9216-6e07-49b9-8faf-bb4e529a6ae5	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Proficient Rx LP	52af51ab-6543-466b-848c-13c588c98789	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	1b73e9db-eddb-49ba-9778-01d39ece4d16	2018-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310430	gabapentin 100 MG Oral Capsule	PSN	76f5eff8-698f-2753-e053-2991aa0ae7f9	12
310431	gabapentin 300 MG Oral Capsule	PSN	76f5eff8-698f-2753-e053-2991aa0ae7f9	12
310432	gabapentin 400 MG Oral Capsule	PSN	76f5eff8-698f-2753-e053-2991aa0ae7f9	12
310430	gabapentin 100 MG Oral Capsule	SCD	76f5eff8-698f-2753-e053-2991aa0ae7f9	12
310431	gabapentin 300 MG Oral Capsule	SCD	76f5eff8-698f-2753-e053-2991aa0ae7f9	12
310432	gabapentin 400 MG Oral Capsule	SCD	76f5eff8-698f-2753-e053-2991aa0ae7f9	12
310430	gabapentin 100 MG Oral Capsule	PSN	20e48004-d8b6-40fd-929b-b95087b4d85d	7
310430	gabapentin 100 MG Oral Capsule	SCD	20e48004-d8b6-40fd-929b-b95087b4d85d	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-047-10	51407004710	1000 CAPSULE in 1 BOTTLE, PLASTIC (51407-047-10)	1000 capsule	2018-09-12	0000-00-00	No	No	Current
51407-047-18	51407004718	180 CAPSULE in 1 BOTTLE, PLASTIC (51407-047-18)	180 capsule	2018-09-12	0000-00-00	No	No	Current
51407-047-27	51407004727	270 CAPSULE in 1 BOTTLE, PLASTIC (51407-047-27)	270 capsule	2018-09-12	0000-00-00	No	No	Current
51407-047-90	51407004790	90 CAPSULE in 1 BOTTLE, PLASTIC (51407-047-90)	90 capsule	2018-09-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Golden State Medical Supply, Inc.	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	12
Gabapentin	Aphena Pharma Solutions - Tennessee, LLC	2022-11-28	HUMAN PRESCRIPTION DRUG LABEL	7