GABAPENTIN

Product NDC: 71610-088
Requested package NDC: 71610-088-53
11-digit product format: 716100088
Labeler code: 71610
Product ID: 71610-088_0515dc32-e7fc-4208-9677-ec9dfad018f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA090007
Marketing category: ANDA
Marketing start: 2015-12-30
Substance: GABAPENTIN
Active strength: 300 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
A090007-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21
A090007-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21
A090007-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090007-001	AB
A090007-002	AB
A090007-003	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	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A090007-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090007-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090007-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090007-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090007-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090007-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090007-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090007-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090007-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-001	AB	1	`301d65b070ca…`

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	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
9d1b9121-c25a-4d28-91c5-5fc72f1167f4	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	SPL version
71610-088-53	GABAPENTIN	60 in 1 BOTTLE	CAPSULE	60	1
71610-088-60	GABAPENTIN	90 in 1 BOTTLE	CAPSULE	90	1
71610-088-80	GABAPENTIN	180 in 1 BOTTLE	CAPSULE	180	1
71610-088-92	GABAPENTIN	270 in 1 BOTTLE	CAPSULE	270	1
71610-088-94	GABAPENTIN	360 in 1 BOTTLE	CAPSULE	360	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-088-53	EA - Each	71610-088	b0f1fee5-920b-43c0-bfd0-ebe7c50d84db	1	2018-09-05
71610-088-60	EA - Each	71610-088	81079a2d-741b-4c36-9435-ec4e7a199bb0	1	2018-09-05
71610-088-80	EA - Each	71610-088	a806d1dc-0ff4-40f4-b072-e7309fe7f1e9	1	2018-09-05
71610-088-92	EA - Each	71610-088	7c9a8696-dd93-4930-a4f5-77be29bef172	1	2018-09-05
71610-088-94	EA - Each	71610-088	9d6cc3e8-8057-4053-b181-be7c5f0f5a43	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-088	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, Legacy NDC, 5 package rows	20180718_9d1b9121-c25a-4d28-91c5-5fc72f1167f4.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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	TIME CAP LABORATORIES, INC	08880902-bd44-41b6-866b-2cbad4c3f2b1	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	9814b76c-87c6-4746-b712-3269352a901b	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	REMEDYREPACK INC.	915cee37-536c-4761-bdb9-b96c7ee0f956	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	DIRECT RX	29a70e2d-d3fd-4e32-95dd-7ee721d87388	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	MARKSANS PHARMA LIMITED	98bb408d-c402-4da6-8f9d-5de4833dedc4	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	11645bd6-7cfe-49b2-9292-2e4b0dbb84ae	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	DIRECT RX	a7e45e3f-e382-32ba-e053-2a95a90a2537	2025-01-17		Exact identifier application applno (ANDA): 090007 application number: ANDA090007
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b062f12c-a745-76d4-e053-2a95a90a3a1a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	c33c4d83-cc13-4104-9e24-d4cd40b17b70	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	e2d9bd8c-3bb9-4945-8e61-7d2703d9008c	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	5769d849-4f27-4701-97ec-7e3ca07339d7	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	78088f6a-06a3-422f-b336-4a57a24adc16	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	8f785189-bf66-36cc-e053-2a95a90a7cbc	2024-06-19		Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	82c0ed15-9132-657d-e053-2991aa0ae90a	2024-06-14		Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	9d1b9121-c25a-4d28-91c5-5fc72f1167f4	2018-07-12		Exact identifier application applno (ANDA): 090007 application number: ANDA090007 ndc (package): 71610-088-53 ndc (product): 71610-088 ndc11 (package): 71610008853
Gabapentin	GABAPENTIN	Bi-Coastal Pharma International LLC	e0cd96d1-b1ef-46ec-a5a3-9505b0811b8b	2016-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007

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	9d1b9121-c25a-4d28-91c5-5fc72f1167f4	1
310431	gabapentin 300 MG Oral Capsule	SCD	9d1b9121-c25a-4d28-91c5-5fc72f1167f4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-088-53	71610008853	60 CAPSULE in 1 BOTTLE (71610-088-53)	60 capsule	2018-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GABAPENTIN - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2018-07-12	HUMAN PRESCRIPTION DRUG LABEL	1