Gabapentin

Product NDC: 72189-524
Requested package NDC: 72189-524-72
11-digit product format: 721890524
Labeler code: 72189
Product ID: 72189-524_4c4aa699-bcdb-17b5-e063-6294a90a2c05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA207099
Marketing category: ANDA
Marketing start: 2023-11-27
Substance: GABAPENTIN
Active strength: 400 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A207099-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24
A207099-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24
A207099-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207099-001	AB
A207099-002	AB
A207099-003	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	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207099-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2017-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207099-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2017-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207099-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2017-03-24	`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	A207099-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207099-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207099-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207099-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207099-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207099-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207099-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207099-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207099-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207099-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207099-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207099-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207099-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207099-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207099-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207099-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207099-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207099-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207099-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207099-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207099-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207099-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207099-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207099-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207099-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207099-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207099-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207099-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207099-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207099-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207099-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207099-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207099-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207099-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207099-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207099-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207099-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207099-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207099-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207099-001	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: 2027-12-31

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
0b286fd1-8179-d87a-e063-6294a90a2f23	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
72189-524-30	Gabapentin	30 in 1 BOTTLE	CAPSULE	30	4
72189-524-60	Gabapentin	60 in 1 BOTTLE	CAPSULE	60	4
72189-524-72	Gabapentin	120 in 1 BOTTLE	CAPSULE	120	4
72189-524-90	Gabapentin	90 in 1 BOTTLE	CAPSULE	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-524-30	EA - Each	72189-524	4aa31dd3-0f68-4237-9982-37a3c4830190	1	2025-05-14
72189-524-60	EA - Each	72189-524	b7b9fcd2-5f4f-44a2-a869-5501b8a90088	1	2024-10-04
72189-524-90	EA - Each	72189-524	61cbe638-dae8-447c-b0d4-002e0d37d49d	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-524	GABAPENTIN CAPSULE [DIRECT_RX]	3	Current NDC, 4 package rows	20250311_0b286fd1-8179-d87a-e063-6294a90a2f23.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
gabapentin	GABAPENTIN	REMEDYREPACK INC.	4a975ebe-ae0a-446a-8a3d-2ca325e28f93	2026-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	596eb696-7696-202e-e063-6394a90a2844	2026-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
gabapentin	GABAPENTIN	REMEDYREPACK INC.	32169228-e85c-4dbf-8722-cd2f8e0f5d1a	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	2bc65375-77b8-1e50-e063-6294a90acf8f	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
gabapentin	GABAPENTIN	Proficient Rx LP	c7674ea5-276b-4bb3-821b-4ac05c9e64e6	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
Gabapentin	GABAPENTIN	Direct_Rx	0b286fd1-8179-d87a-e063-6294a90a2f23	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099 ndc (package): 72189-524-72 ndc (product): 72189-524 ndc11 (package): 72189052472
gabapentin	GABAPENTIN	Coupler LLC	47cd25f6-e123-9aaf-e063-6394a90aeedd	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
gabapentin	GABAPENTIN	Northwind Health Company, LLC	471b2d32-0cbd-aade-e063-6394a90a1696	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
gabapentin	GABAPENTIN	Coupler LLC	3eeda97d-c3cd-65cd-e063-6394a90aae8b	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
Gabapentin	GABAPENTIN	Direct_Rx	2cb1ad6d-d389-4564-e063-6394a90a3644	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
gabapentin	GABAPENTIN	Rising Pharma Holdings, Inc.	969cccfc-e56a-49da-9d36-47c0c3fad7f8	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
Gabapentin	GABAPENTIN	Proficient Rx LP	64a65366-8577-48f2-9f8e-0332f126d3c1	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099
Gabapentin	GABAPENTIN	Epic Pharma, LLC	030e656a-e384-49ac-830f-32140c18112d	2019-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207099 application number: ANDA207099

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	0b286fd1-8179-d87a-e063-6294a90a2f23	4
310432	gabapentin 400 MG Oral Capsule	SCD	0b286fd1-8179-d87a-e063-6294a90a2f23	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-524-72	72189052472	120 CAPSULE in 1 BOTTLE (72189-524-72)	120 capsule	2023-11-27	No	No	Current