GABAPENTIN

Product NDC: 80425-0595
11-digit product format: 804250595
Labeler code: 80425
Product ID: 80425-0595_5b3ba5e9-6e97-dea6-e063-6394a90aa2bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA214956
Marketing category: ANDA
Marketing start: 2026-09-11
Substance: GABAPENTIN
Active strength: 100 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
A214956-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10
A214956-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10
A214956-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214956-001	AB
A214956-002	AB
A214956-003	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 · 105 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	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214956-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2021-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214956-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2021-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214956-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2021-05-10	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 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	A214956-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214956-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214956-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214956-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214956-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214956-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214956-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214956-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214956-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214956-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214956-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214956-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214956-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214956-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214956-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214956-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214956-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214956-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214956-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214956-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214956-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214956-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214956-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214956-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214956-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214956-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214956-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214956-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214956-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214956-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214956-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214956-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214956-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214956-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214956-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214956-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214956-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214956-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214956-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214956-001	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	100 mg/1

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	St. Mary's Medical Park Pharmacy	235a6954-318a-9e3a-e063-6394a90a0e21	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	dd0e12c2-1986-4ca3-a809-d703a7542419	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	4aa69d04-6b32-4764-a48b-ef5313dd95d3	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	43a3ec78-8235-4d46-a343-2f9226745a39	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	685553b0-384e-400b-a8ae-612ceece8261	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	7ea0b220-edbb-45eb-aeb3-65283f8489a1	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	Northwind Health Company, LLC	47214c7c-ba1b-9107-e063-6294a90a5431	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	Redpharm Drug	44f2b497-55b2-864f-e063-6294a90ad6d5	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	XLCare Pharmaceuticals, Inc.	618c948d-deee-44e2-98f0-e5232171dd50	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals, Inc.	200b61d7-6e4c-923d-e063-6294a90a42cf	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	35ac6b11-7b1c-47a0-a4ba-c193a0bb5b01	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	2b395a14-0f8e-7f5b-e063-6294a90ab546	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	Camber Pharmaceuticals, Inc.	e8a30eb7-3fc5-456a-bdae-3f4095bf2c2b	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	17a62334-209d-4dc1-867a-e5780196a2ca	2024-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	f38098ec-dd1a-405a-bbfb-bad62e4e7fa5	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214956 application number: ANDA214956

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0595-1	80425059501	30 CAPSULE in 1 BOTTLE (80425-0595-1)	30 capsule	2026-09-11	No	No	Current
80425-0595-2	80425059502	60 CAPSULE in 1 BOTTLE (80425-0595-2)	60 capsule	2026-09-11	No	No	Current
80425-0595-3	80425059503	90 CAPSULE in 1 BOTTLE (80425-0595-3)	90 capsule	2026-09-11	No	No	Current
80425-0595-4	80425059504	120 CAPSULE in 1 BOTTLE (80425-0595-4)	120 capsule	2026-09-11	No	No	Current