GABAPENTIN

Product NDC: 68788-8176
11-digit product format: 687888176
Labeler code: 68788
Product ID: 68788-8176_1e741495-a619-41e4-a466-0d2fb79df358
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA075360
Marketing category: ANDA
Marketing start: 2022-04-27
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-8176		D	Discontinued by firm	2026-09-09
excluded package	package	68788-8176	68788-8176-1	D	Discontinued by firm	2026-09-09
excluded package	package	68788-8176	68788-8176-3	D	Discontinued by firm	2026-09-09
excluded package	package	68788-8176	68788-8176-6	D	Discontinued by firm	2026-09-09
excluded package	package	68788-8176	68788-8176-8	D	Discontinued by firm	2026-09-09
excluded package	package	68788-8176	68788-8176-9	D	Discontinued by firm	2026-09-09

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075360-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06
A075360-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06
A075360-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075360-001	AB
A075360-002	AB
A075360-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075360-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075360-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075360-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075360-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075360-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075360-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075360-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075360-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075360-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075360-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075360-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075360-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075360-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075360-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075360-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075360-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075360-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075360-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075360-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8176-1	EA - Each	68788-8176	7d3dacca-688f-48ea-ad47-e31102fa9a22	1	2022-07-06
68788-8176-3	EA - Each	68788-8176	210fb03f-cc7f-4809-bcc3-e5b02ecbcb68	1	2022-07-06
68788-8176-6	EA - Each	68788-8176	db014158-166a-4d58-89d4-3452b8049a4c	1	2022-07-06
68788-8176-8	EA - Each	68788-8176	e06cd5e0-8beb-445d-95f3-00d9cacef698	1	2022-07-06
68788-8176-9	EA - Each	68788-8176	fe720e95-8092-4941-8b1d-3b91d1f1f5c4	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8176	GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]	3	Legacy NDC	20240504_1e741495-a619-41e4-a466-0d2fb79df358.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	Granules Pharmaceuticals Inc	c681c804-c6f3-d63b-e053-2995a90a6b8f	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	397fd6d3-317b-4b61-a52b-3a09ca1d88a4	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	13640281-26b4-402e-8f69-7c81cd6e0376	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	ST. MARY'S MEDICAL PARK PHARMACY	3aaf3d6e-c6d5-89f5-e063-6394a90a9b77	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Granules Pharmaceuticals Inc.	b20ee34a-7f2d-4d62-a161-898565f74547	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c859e666-d510-426b-e053-2995a90a9a3c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	5fb79774-c2d4-47ba-9a16-eb367d0fdcff	2023-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Proficient Rx LP	aa3ab216-372a-4a72-bfd1-88a1ffa31ba3	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360
GABAPENTIN	GABAPENTIN	Proficient Rx LP	185f264e-db32-41cd-b90d-519717b97850	2021-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075360 application number: ANDA075360

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	Marketing end	Sample	Exclude flag	Status
68788-8176-1	68788817601	100 CAPSULE in 1 BOTTLE (68788-8176-1)	100 capsule	2022-04-27	0000-00-00	No	No	Current
68788-8176-3	68788817603	30 CAPSULE in 1 BOTTLE (68788-8176-3)	30 capsule	2022-04-27	0000-00-00	No	No	Current
68788-8176-6	68788817606	60 CAPSULE in 1 BOTTLE (68788-8176-6)	60 capsule	2022-04-27	0000-00-00	No	No	Current
68788-8176-8	68788817608	120 CAPSULE in 1 BOTTLE (68788-8176-8)	120 capsule	2022-04-27	0000-00-00	No	No	Current
68788-8176-9	68788817609	90 CAPSULE in 1 BOTTLE (68788-8176-9)	90 capsule	2022-04-27	0000-00-00	No	No	Current