Gabapentin

Product NDC: 45865-194
11-digit product format: 458650194
Labeler code: 45865
Product ID: 45865-194_12f0b9ce-f0ff-fa26-e063-6394a90aa686
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA204989
Marketing category: ANDA
Marketing start: 2016-02-18
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

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 · 128 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	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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204989-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2016-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204989-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2016-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204989-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2016-02-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 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	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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204989-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204989-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204989-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204989-003	AB	1	`301d65b070ca…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	300 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310431	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
12f0c2ee-9a44-9778-e063-6294a90a3b58	Available on FDA.report

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
45865-194-30	Gabapentin	30 in 1 BOTTLE	CAPSULE	30	1
45865-194-51	Gabapentin	120 in 1 BOTTLE	CAPSULE	120	1
45865-194-60	Gabapentin	60 in 1 BOTTLE	CAPSULE	60	1
45865-194-90	Gabapentin	90 in 1 BOTTLE	CAPSULE	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-194	GABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]	1	Current NDC, 4 package rows	20240307_12f0c2ee-9a44-9778-e063-6294a90a3b58.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 3 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	b8b7e045-a7fe-8539-e053-2a95a90a40f8	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	100ff86c-56a8-4770-9db3-b9bc6b1bd2f7	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	e3429322-c442-4146-bb68-bcc3a8d01552	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204989 application number: ANDA204989
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	2625c0ef-5295-41de-9e81-88001a6cbecc	2026-04-29	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
310431	gabapentin 300 MG Oral Capsule	PSN	12f0c2ee-9a44-9778-e063-6294a90a3b58	1
310431	gabapentin 300 MG Oral Capsule	SCD	12f0c2ee-9a44-9778-e063-6294a90a3b58	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
45865-194-30	45865019430	30 CAPSULE in 1 BOTTLE (45865-194-30)	30 capsule	2021-08-31	No	No	Current
45865-194-51	45865019451	120 CAPSULE in 1 BOTTLE (45865-194-51)	120 capsule	2022-10-18	No	No	Current
45865-194-60	45865019460	60 CAPSULE in 1 BOTTLE (45865-194-60)	60 capsule	2021-09-09	No	No	Current
45865-194-90	45865019490	90 CAPSULE in 1 BOTTLE (45865-194-90)	90 capsule	2021-08-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Medsource Pharmaceuticals \| ScieGen Pharmaceuticals, Inc.	2024-03-05	HUMAN PRESCRIPTION DRUG LABEL	1