Gabapentin

Product NDC: 72162-1813
Requested package NDC: 72162-1813-6
11-digit product format: 721621813
Labeler code: 72162
Product ID: 72162-1813_e8a268d7-a080-4540-8ac9-63201fd965e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078428
Marketing category: ANDA
Marketing start: 2009-11-24
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 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
A078428-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25
A078428-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25
A078428-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078428-001	AB
A078428-002	AB
A078428-003	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	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`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	A078428-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078428-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078428-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078428-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078428-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078428-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078428-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-001	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
7b404ab9-8a7e-49d4-920f-487875d14e45	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
72162-1813-1	Gabapentin	100 in 1 BOTTLE	CAPSULE	100	103
72162-1813-2	Gabapentin	120 in 1 BOTTLE	CAPSULE	120	103
72162-1813-4	Gabapentin	20 in 1 BOTTLE	CAPSULE	20	103
72162-1813-6	Gabapentin	60 in 1 BOTTLE	CAPSULE	60	103
72162-1813-7	Gabapentin	180 in 1 BOTTLE	CAPSULE	180	103
72162-1813-8	Gabapentin	84 in 1 BOTTLE	CAPSULE	84	103
72162-1813-9	Gabapentin	90 in 1 BOTTLE	CAPSULE	90	103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1813-1	EA - Each	72162-1813	8856c4e8-137b-44a5-808d-f98066f19826	1	2023-10-16
72162-1813-2	EA - Each	72162-1813	a183c871-091d-44cf-9543-d7001ec1c283	1	2023-10-16
72162-1813-4	EA - Each	72162-1813	b07e71dd-2f20-45ee-991b-6c6439d04975	1	2023-10-16
72162-1813-6	EA - Each	72162-1813	9e445edb-c461-4927-b6b3-e05adc58973d	1	2023-10-16
72162-1813-7	EA - Each	72162-1813	c96e5a2f-b40c-487c-ba7d-b9d07d0426c2	1	2023-10-16
72162-1813-8	EA - Each	72162-1813	67d0ac8a-2d12-4499-a0a3-e52e90e6285b	1	2023-10-16
72162-1813-9	EA - Each	72162-1813	ab614c8e-b9c9-4442-bd0b-61e9a0f3be0e	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1813	GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]	103	Current NDC, 7 package rows	20241122_7b404ab9-8a7e-49d4-920f-487875d14e45.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54dc347e-cba0-ea73-e063-6294a90ab436	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Amneal Pharmaceuticals LLC	507bf6d0-e7a2-413d-9848-cd2445a1411d	2026-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	7b404ab9-8a7e-49d4-920f-487875d14e45	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428 ndc (package): 72162-1813-6 ndc (product): 72162-1813 ndc11 (package): 72162181306
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	657349fb-41a9-4814-b4ac-4c5afbdde947	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a15d5dcc-63c4-4c06-ab91-5e22cdf234cc	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	477691f5-0591-4544-840a-ac590e1f25a1	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	506bf880-9564-404c-951a-703797ffdad8	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	dbedccfb-0e27-4119-93b9-241c039e045a	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Amneal Pharmaceuticals of New York LLC	b11dbff5-ceee-4a63-a093-f6efebdc2f6f	2021-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428

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	7b404ab9-8a7e-49d4-920f-487875d14e45	103
310431	gabapentin 300 MG Oral Capsule	SCD	7b404ab9-8a7e-49d4-920f-487875d14e45	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1813-6	72162181306	60 CAPSULE in 1 BOTTLE (72162-1813-6)	60 capsule	2024-11-01	No	No	Current