Gabapentin

Product NDC: 85534-0003
11-digit product format: 855340003
Labeler code: 85534
Product ID: 85534-0003_559e72cb-a7f3-e1ed-e063-6294a90ad90a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: HAWAII REPACK, INC.
Application: ANDA204989
Marketing category: ANDA
Marketing start: 2016-02-18
Substance: GABAPENTIN
Active strength: 100 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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.

Additional Listing Data#

Finished product: Yes
Brand name base: Gabapentin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6CW7F3G59X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310430	Internal RxNorm lookup
310431	Internal RxNorm lookup
310432	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
dd7adad2-e2f5-4b43-90a4-522bce0be5b3	Available on FDA.report

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 3 · 54 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	d35cd5ac-5ed6-2405-e053-2995a90a6946	2026-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	1af098ad-28b5-463f-8efa-24d70a77d64c	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	9a2658d5-9b0e-4921-b4c5-4c89f1630d69	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	43cbff48-8219-41ba-b67d-3ae4544b78bb	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Trifluent Pharma, LLC	59442de1-7cf0-35f6-e063-6294a90a57d7	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	cb81fd89-b32b-4538-bf5c-ab02f65b3458	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	691205ba-fa65-4bc9-ba20-7d361382cff9	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	97e47698-97c9-4eb5-a108-5850c2aa2818	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2ac0622c-440a-49a0-974f-726e6ac72a0e	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	48037fc4-1aab-4ae8-aede-7c55b494877a	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	e877a425-2b7f-4e43-a1f9-24019cbf9685	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	ScieGen Pharmaceuticals, Inc.	16542ee6-0e0e-4d3c-8b32-60ff6ef48846	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	dd7adad2-e2f5-4b43-90a4-522bce0be5b3	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989 ndc (product): 85534-0003
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	1b44a3ab-4d06-205f-e063-6294a90af368	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	9a829dc3-b2d8-4d19-a579-0597217cec9b	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	b7a29b99-ce23-950e-e053-2995a90a1934	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	4c49d34d-bb47-406b-8f2d-b4834b2ee9d0	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Coupler LLC	5385e27c-f2fa-32d5-e063-6294a90a0a8c	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Direct_Rx	f8998c1c-c359-6f01-e053-6294a90aebf4	2026-06-01	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85534-0003-0	85534000300	30 CAPSULE in 1 BOTTLE, PLASTIC (85534-0003-0)	30 capsule	2026-07-02	No	No	Current
85534-0003-1	85534000301	60 CAPSULE in 1 BOTTLE, PLASTIC (85534-0003-1)	60 capsule	2026-07-02	No	No	Current
85534-0003-2	85534000302	90 CAPSULE in 1 BOTTLE, PLASTIC (85534-0003-2)	90 capsule	2026-07-02	No	No	Current
85534-0003-3	85534000303	120 CAPSULE in 1 BOTTLE, PLASTIC (85534-0003-3)	120 capsule	2026-07-02	No	No	Current