Gabapentin

Product NDC: 80175-0662
11-digit product format: 801750662
Labeler code: 80175
Product ID: 80175-0662_bdc0aa15-7ec2-ea98-e053-2a95a90ac0dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Central Packaging
Application: ANDA078787
Marketing category: ANDA
Marketing start: 2008-01-31
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	80175-0662		I	Inactivated by FDA		2026-10-05
excluded package	package	80175-0662	80175-0662-9	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80175-0662-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80175-0662-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80175-0662-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80175-0662-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80175-0662-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80175-0662-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80175-0662-9	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80175-0662-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80175-0662-9	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	80175-0662-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	80175-0662-9	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	80175-0662-9	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	80175-0662-9	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	80175-0662-9	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	80175-0662-9	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	80175-0662-9	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	80175-0662-9	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	80175-0662-9	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	80175-0662-9	`8dfbde2a14a4…`	`c9ff85d89658…`

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
A078787-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31
A078787-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31
A078787-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078787-001	AB
A078787-002	AB
A078787-003	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	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`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	A078787-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078787-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078787-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078787-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078787-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078787-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078787-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078787-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078787-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	Strength	SPL version
80175-0662-9	Gabapentin	90 in 1 BOTTLE	CAPSULE	90		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80175-0662	GABAPENTIN CAPSULE [CENTRAL PACKAGING]	1	Legacy NDC, 1 package rows	20210225_bc1b507d-9b2a-5328-e053-2995a90a1264.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Redpharm Drug	58474aa7-7c6a-3a94-e063-6394a90a870b	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	6beed8eb-446c-4575-8dc8-b798623d92c7	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	912d8697-b466-48dc-88d3-d2ba90e76644	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	3dbd447f-4791-4c62-86b4-6f7928862785	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	67330eef-c976-4862-b1ae-20f30f43df76	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	efb86e22-5a84-4b33-aad0-71dd5a2c6c8f	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	eaf5e41e-8ed3-404e-84e0-392bebdbc0b7	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	344d67fa-092e-4e71-b96a-25c71bfa6bb1	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	bc1316b6-1fc4-4990-95a8-489881772876	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	NorthStar Rx LLC	f7c1fd34-d615-43a2-8989-898fe11f90df	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	d25daaac-a8ab-4f12-acc2-4ec8fc97a2d4	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Aurobindo Pharma Limited	1a619a14-0b63-4cba-80e7-474c9a1c90b9	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b33c18ea-554d-3cfb-e053-2a95a90a2dd1	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	bc08e35d-ef5d-1dcd-e053-2a95a90ab5de	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ff28c5f1-da56-4072-a6fa-d689d4a6761b	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1e28ad3d-2d34-a5d0-e063-6294a90adb9e	2024-07-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	ecb798a0-377d-4712-bb82-ec9d7116962f	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	3b4395f2-9440-4b67-97cc-5d16f3bdd05e	2020-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Proficient Rx LP	ded42b88-94dd-462d-bcdf-7fd34d1e49c3	2020-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Proficient Rx LP	7d77dae0-df76-4b7b-9690-713e9a60e3cd	2019-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787

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	bc1b507d-9b2a-5328-e053-2995a90a1264	1
310431	gabapentin 300 MG Oral Capsule	SCD	bc1b507d-9b2a-5328-e053-2995a90a1264	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80175-0662-9	80175066209	90 CAPSULE in 1 BOTTLE (80175-0662-9)	90 capsule	2008-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin - Central Packaging \| Central Packaging, LLC	Central Packaging \| Central Packaging, LLC	2021-02-24	HUMAN PRESCRIPTION DRUG LABEL	1