Gabapentin

Product NDC: 71093-161
Requested package NDC: 71093-161-05
11-digit product format: 710930161
Labeler code: 71093
Product ID: 71093-161_34215928-9270-4000-898a-2449edc02676
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: ACI Healthcare USA, Inc.
Application: ANDA213603
Marketing category: ANDA
Marketing start: 2021-05-03
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 100 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71093-161	71093-161-05	I	Inactivated by FDA		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A213603-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17
A213603-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17
A213603-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213603-001	AB
A213603-002	AB
A213603-003	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 3 · 117 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	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2020-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2020-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213603-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2020-08-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A213603-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213603-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213603-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213603-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213603-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213603-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213603-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213603-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213603-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213603-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213603-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213603-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213603-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213603-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213603-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213603-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213603-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213603-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213603-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71093-161-04	2025-01-30	C162847	48780-1	2cef2736-5ad9-d83d-e063-dadaa90ab31f	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
71093-161-05	2025-01-30	C162847	48780-1	2cef2736-5ad9-d83d-e063-dadaa90ab31f	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
71093-161-04	Gabapentin	100 in 1 BOTTLE	CAPSULE	100		10
71093-161-05	Gabapentin	500 in 1 BOTTLE	CAPSULE	500		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71093-161-04	EA - Each	71093-161	4c249763-d802-42a3-a004-18b8e6e1b263	1	2021-05-05
71093-161-05	EA - Each	71093-161	ea6447f5-efd4-4c5d-b4c7-d9cedbadf6fe	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71093-161	GABAPENTIN CAPSULE [ACI HEALTHCARE USA, INC.]	10	Legacy NDC, 2 package rows	20231217_f2d9c3de-4749-4265-a26e-50026ab46ee4.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Zhejiang Yongtai Pharmaceutical Co., Ltd	f1eda6cc-d9b2-4df4-a09b-20eebded760f	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603
Gabapentin	GABAPENTIN	Direct_Rx	e90d2e3d-ec86-7d1d-e053-2995a90a9167	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2dad630a-09d8-4f40-bdad-24e877a9ee38	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ffe5321d-3405-46d5-a75f-c51e8f8d87b1	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213603 application number: ANDA213603

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
310430	gabapentin 100 MG Oral Capsule	PSN	f2d9c3de-4749-4265-a26e-50026ab46ee4	10
310431	gabapentin 300 MG Oral Capsule	PSN	f2d9c3de-4749-4265-a26e-50026ab46ee4	10
310432	gabapentin 400 MG Oral Capsule	PSN	f2d9c3de-4749-4265-a26e-50026ab46ee4	10
310430	gabapentin 100 MG Oral Capsule	SCD	f2d9c3de-4749-4265-a26e-50026ab46ee4	10
310431	gabapentin 300 MG Oral Capsule	SCD	f2d9c3de-4749-4265-a26e-50026ab46ee4	10
310432	gabapentin 400 MG Oral Capsule	SCD	f2d9c3de-4749-4265-a26e-50026ab46ee4	10
310430	gabapentin 100 MG Oral Capsule	PSN	e90d2e3d-ec86-7d1d-e053-2995a90a9167	4
310430	gabapentin 100 MG Oral Capsule	SCD	e90d2e3d-ec86-7d1d-e053-2995a90a9167	4
310430	gabapentin 100 MG Oral Capsule	PSN	0100d63a-b906-110c-e063-6294a90a541b	2
310430	gabapentin 100 MG Oral Capsule	SCD	0100d63a-b906-110c-e063-6294a90a541b	2
310430	gabapentin 100 MG Oral Capsule	PSN	042a054d-1576-8427-e063-6394a90a1e08	1
310430	gabapentin 100 MG Oral Capsule	SCD	042a054d-1576-8427-e063-6394a90a1e08	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71093-161-05	71093016105	500 CAPSULE in 1 BOTTLE (71093-161-05)	500 capsule	2021-05-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	4
Gabapentin	NuCare Pharmaceuticals,Inc.	2023-08-30	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	ACI Healthcare USA, Inc. \| Zhejiang Yongtai Pharmaceutical Co., Ltd	2023-08-19	HUMAN PRESCRIPTION DRUG LABEL	10
Gabapentin	NuCare Pharmaceuticals,Inc.	2023-08-09	HUMAN PRESCRIPTION DRUG LABEL	2