GABAPENTIN

Product NDC: 68788-8176
Requested package NDC: 68788-8176-3
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	68788-8176	68788-8176-3	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-11-12 20:34 UTC	2022-11	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`3a93d1ddd44b…`
2022-11-12 20:34 UTC	2022-11	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`3a93d1ddd44b…`
2022-11-12 20:34 UTC	2022-11	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A075360-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-04-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075360-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-04-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075360-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-04-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC	2022-11	A075360-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC	2022-11	A075360-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC	2022-11	A075360-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075360-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075360-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075360-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075360-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075360-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A075360-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075360-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075360-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075360-003	AB	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A075360-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075360-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075360-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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
68788-8176-3	68788817603	30 CAPSULE in 1 BOTTLE (68788-8176-3)	30 capsule	2022-04-27	0000-00-00	No	No	Current