Gabapentin

Product NDC: 68071-5193
11-digit product format: 680715193
Labeler code: 68071
Product ID: 68071-5193_263011b9-09a2-e225-e063-6394a90a3364
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA090858
Marketing category: ANDA
Marketing start: 2011-01-29
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090858-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17
A090858-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17
A090858-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090858-001	AB
A090858-002	AB
A090858-003	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 · 123 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	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A090858-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090858-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090858-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090858-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090858-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090858-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090858-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090858-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090858-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090858-001	AB	1	`8072bd15b7f6…`

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
a072d5d2-8c75-59cc-e053-2a95a90ac0cc	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
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5193-3	2022-02-07	C162847	48780-1	d6a99b39-6d4d-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use Initial U.S. Approval: 1993
68071-5193-3	2022-01-28	C162847	48780-1	d6a99b39-6d4d-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-5193-3	Gabapentin	30 in 1 BOTTLE	CAPSULE	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5193	GABAPENTIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 1 package rows	20241107_a072d5d2-8c75-59cc-e053-2a95a90ac0cc.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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Ascend Laboratories, LLC	722de2a9-38b3-4518-b262-ba0d1346d0ba	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a1006139-7dfc-4d87-a5a9-aeb380c32d24	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	896c7782-1137-454b-aaa6-28f42c7413ef	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6a0a75ac-e121-477b-a9d1-d11f588afc9d	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	7652adc6-1aad-4422-b85c-0c6b11c23b73	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	d06380d0-c894-427e-b13e-5a8f9eb86a34	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	78445dbf-c7cd-419f-a7be-72821e496628	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Major Pharmaceuticals	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	14d61caa-17ce-4fa2-90fb-1470f3864be8	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	552912b2-be59-0333-e063-6394a90a85c0	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	55292235-bf8f-46d0-e063-6294a90a91a5	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	3e633cd0-5ee8-4a05-bcfc-0a80209bf27f	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54ecc64b-f019-9fcb-e063-6294a90a00af	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	ddb3a54f-5224-4024-8804-b2a2f01d885e	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	41844c21-9e2a-4332-a8ff-9b71ae9032b0	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	A-S Medication Solutions	03031adf-d36b-45ec-944e-dfce5a5de91a	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	d4f21e97-5e55-44c9-9b31-5f79ac2eb512	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Major Pharmaceuticals	999f3685-2eac-467e-bed2-1d0c36aaf0ed	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	fce0c123-29d7-42bf-8c8d-8be1772e2d99	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afc83432-8fce-6d2a-e053-2a95a90ae73f	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858

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	a072d5d2-8c75-59cc-e053-2a95a90ac0cc	4
310431	gabapentin 300 MG Oral Capsule	SCD	a072d5d2-8c75-59cc-e053-2a95a90ac0cc	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5193-3	68071519303	30 CAPSULE in 1 BOTTLE (68071-5193-3)	30 capsule	2020-03-09	0000-00-00	No	No	Current