Gabapentin

Product NDC: 71610-059
11-digit product format: 716100059
Labeler code: 71610
Product ID: 71610-059_5d754fbf-428a-4871-963b-328fce55e292
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA090858
Marketing category: ANDA
Marketing start: 2011-01-29
Substance: GABAPENTIN
Active strength: 400 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], 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 43.

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 · 129 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	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-05-31 18:47 UTC	2024-05	A090858-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090858-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090858-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090858-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090858-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090858-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090858-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090858-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090858-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090858-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090858-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090858-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090858-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090858-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090858-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090858-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090858-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090858-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090858-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090858-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090858-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090858-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090858-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090858-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090858-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090858-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090858-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090858-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090858-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090858-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090858-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090858-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090858-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090858-002	AB	1	`3f01610625f2…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	400 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
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
6fc8e8b2-5d0e-4c72-9a46-6d312c3efac7	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-059-60	Gabapentin	90 in 1 BOTTLE	CAPSULE	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-059-60	EA - Each	71610-059	146a9c9e-e339-4c1e-b160-9382cfb0432f	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-059	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20180514_6fc8e8b2-5d0e-4c72-9a46-6d312c3efac7.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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	09736975-2493-4dbc-bbe0-cc56a1fec53f	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	A-S Medication Solutions	c979f80b-d4b1-40f7-b878-b216db5f325d	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	American Health Packaging	bbfdedd7-2baf-4bc6-be59-548a5cf21752	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	McKesson Corporation dba Sky Packaging	23eb133e-2f74-4219-9892-0a8e770ec032	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	743faa18-5e7c-4fcc-9781-4157450d90c4	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c89a68b6-6dc0-4624-e053-2a95a90a687e	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a072d5d2-8c75-59cc-e053-2a95a90ac0cc	2024-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	A-S Medication Solutions	77d1d90d-e124-4db7-b811-754d535e579c	2023-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Proficient Rx LP	176c5b60-93c2-4574-8b51-c15180912aaa	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	14b1840d-a2db-4eec-bc25-029e35b042e4	2022-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Proficient Rx LP	2ef99c3d-866a-438b-a340-8beba8d4c457	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	f455b415-12a2-4916-b826-246976a8af44	2018-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	6fc8e8b2-5d0e-4c72-9a46-6d312c3efac7	2018-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858 ndc (product): 71610-059

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
310432	gabapentin 400 MG Oral Capsule	PSN	6fc8e8b2-5d0e-4c72-9a46-6d312c3efac7	1
310432	gabapentin 400 MG Oral Capsule	SCD	6fc8e8b2-5d0e-4c72-9a46-6d312c3efac7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-059-60	71610005960	90 CAPSULE in 1 BOTTLE (71610-059-60)	90 capsule	2018-05-09	0000-00-00	No	No	Current