Gabapentin

Product NDC: 42495-266
11-digit product format: 424950266
Labeler code: 42495
Product ID: 42495-266_9e656733-a7aa-43d2-b11f-e87f6e15d64d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: CAPSULE
Route: ORAL
Labeler: MSM Repackaging
Application: ANDA090007
Marketing category: ANDA
Marketing start: 2012-10-15
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: E
Listing certified through: 2017-12-31
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	42495-266		I	Inactivated by FDA		2026-08-11
excluded package	package	42495-266	42495-266-30	I	Inactivated by FDA		2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42495-266-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42495-266-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42495-266-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42495-266-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42495-266-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42495-266-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42495-266-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42495-266-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42495-266-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42495-266-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42495-266-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42495-266-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42495-266-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42495-266-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42495-266-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42495-266-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42495-266-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42495-266-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42495-266-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42495-266-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42495-266-30	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42495-266-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A090007-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21
A090007-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21
A090007-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090007-001	AB
A090007-002	AB
A090007-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090007-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2011-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090007-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2011-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090007-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2011-07-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090007-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090007-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090007-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090007-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090007-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090007-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090007-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090007-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090007-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090007-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090007-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090007-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090007-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090007-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090007-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090007-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090007-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090007-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090007-001	AB	1	`8072bd15b7f6…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42495-266-30	2020-01-31	C162847	48780-1	9d75b9d0-7b25-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42495-266-30	Gabapentin	30 in 1 BLISTER PACK	CAPSULE	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [MSM REPACKAGING ]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [MSM REPACKAGING ]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GABAPENTIN CAPSULE [MSM REPACKAGING ]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [MSM REPACKAGING ]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [MSM REPACKAGING ]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GABAPENTIN CAPSULE [MSM REPACKAGING ]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABAPENTIN CAPSULE [MSM REPACKAGING ]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [MSM REPACKAGING ]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [MSM REPACKAGING ]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [MSM REPACKAGING ]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [MSM REPACKAGING ]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42495-266	GABAPENTIN CAPSULE [MSM REPACKAGING ]	1	Legacy NDC, 1 package rows	20151007_b7cf18b4-f114-434b-9a4c-0c40b1a2b47d.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	TIME CAP LABORATORIES, INC	08880902-bd44-41b6-866b-2cbad4c3f2b1	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	9814b76c-87c6-4746-b712-3269352a901b	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	REMEDYREPACK INC.	915cee37-536c-4761-bdb9-b96c7ee0f956	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	DIRECT RX	29a70e2d-d3fd-4e32-95dd-7ee721d87388	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	MARKSANS PHARMA LIMITED	98bb408d-c402-4da6-8f9d-5de4833dedc4	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	11645bd6-7cfe-49b2-9292-2e4b0dbb84ae	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	DIRECT RX	a7e45e3f-e382-32ba-e053-2a95a90a2537	2025-01-17		Exact identifier application applno (ANDA): 090007 application number: ANDA090007
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b062f12c-a745-76d4-e053-2a95a90a3a1a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	c33c4d83-cc13-4104-9e24-d4cd40b17b70	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	e2d9bd8c-3bb9-4945-8e61-7d2703d9008c	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	5769d849-4f27-4701-97ec-7e3ca07339d7	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	78088f6a-06a3-422f-b336-4a57a24adc16	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	8f785189-bf66-36cc-e053-2a95a90a7cbc	2024-06-19		Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	82c0ed15-9132-657d-e053-2991aa0ae90a	2024-06-14		Exact identifier application applno (ANDA): 090007 application number: ANDA090007
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	9d1b9121-c25a-4d28-91c5-5fc72f1167f4	2018-07-12		Exact identifier application applno (ANDA): 090007 application number: ANDA090007
Gabapentin	GABAPENTIN	Bi-Coastal Pharma International LLC	e0cd96d1-b1ef-46ec-a5a3-9505b0811b8b	2016-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090007 application number: ANDA090007

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	b7cf18b4-f114-434b-9a4c-0c40b1a2b47d	1
310431	gabapentin 300 MG Oral Capsule	SCD	b7cf18b4-f114-434b-9a4c-0c40b1a2b47d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42495-266-30	42495026630	30 in 1 BLISTER PACK	Historical