Gabapentin

Product NDC: 0228-2636
11-digit product format: 002282636
Labeler code: 0228
Product ID: 0228-2636_aea65b96-e213-4141-8c3f-3eb4650985f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA075694
Marketing category: ANDA
Marketing start: 2004-02-14
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 600 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
unfinished product	product	0228-2636		UNFINISHED	Active or certified unfinished drug listing	2026-08-12
unfinished package	package	0228-2636	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	2026-08-12
unfinished package	package	0228-2636	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	2026-08-12
excluded product	product	0228-2636		D	Discontinued by firm	2026-08-11
excluded package	package	0228-2636	0228-2636-11	D	Discontinued by firm	2026-08-11
excluded package	package	0228-2636	0228-2636-50	D	Discontinued by firm	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 2 · 62 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	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0228-2636-11	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0228-2636-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0228-2636-11	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0228-2636-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	0228-2636-77	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	0228-2636-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075694-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL			2004-10-21
A075694-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL			2004-10-21

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 · 82 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	A075694-001	GABAPENTIN	600MG	TABLET / ORAL		2004-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075694-002	GABAPENTIN	800MG	TABLET / ORAL		2004-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075694-001	GABAPENTIN	600MG	TABLET / ORAL		2004-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075694-002	GABAPENTIN	800MG	TABLET / ORAL		2004-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075694-001	GABAPENTIN	600MG	TABLET / ORAL		2004-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075694-002	GABAPENTIN	800MG	TABLET / ORAL		2004-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2004-10-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2004-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2004-10-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2004-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2004-10-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2004-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2004-10-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2004-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2004-10-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2004-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2004-10-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2004-10-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075694-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075694-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075694-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075694-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075694-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075694-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075694-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075694-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075694-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075694-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075694-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075694-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075694-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075694-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075694-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075694-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075694-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075694-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075694-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075694-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075694-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075694-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075694-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075694-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075694-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075694-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075694-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075694-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075694-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075694-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075694-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075694-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075694-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075694-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075694-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075694-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075694-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075694-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075694-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075694-002	AB	1	`8869cabd3fbd…`

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	600 mg/1

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0228-2636-11	EA - Each	0228-2636	500bb6b2-8afb-4aff-9de4-5821ece7855d	1	2012-07-24
0228-2636-50	EA - Each	0228-2636	792ba34e-3849-44f3-8a51-ece5c566de5d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	18
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	18
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	18
CROSPOVIDONE (15 MPA.S AT 5%)	INACTIVE INGREDIENT	68401960MK	GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	18
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	18
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	18
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	18
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	18
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	18
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	18
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	18
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
CROSPOVIDONE (15 MPA.S AT 5%)	INACTIVE INGREDIENT	68401960MK	GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [PROFICIENT RX]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [PROFICIENT RX]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	GABAPENTIN TABLET, FILM COATED [PROFICIENT RX]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	GABAPENTIN TABLET, FILM COATED [PROFICIENT RX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GABAPENTIN TABLET, FILM COATED [PROFICIENT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN TABLET, FILM COATED [PROFICIENT RX]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN TABLET, FILM COATED [PROFICIENT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET, FILM COATED [PROFICIENT RX]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET, FILM COATED [PROFICIENT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET, FILM COATED [PROFICIENT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0228-2636	GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	35	Legacy NDC	20241027_a33dd4d8-7d6e-4d15-ae49-9c400059c794.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	Marketing start	Marketing end	Sample	Exclude flag	Status
0228-2636-00	00228263600	14300 TABLET, FILM COATED in 1 BAG (0228-2636-00)	06-MAY-15				Current
0228-2636-11	00228263611	100 TABLET, FILM COATED in 1 BOTTLE (0228-2636-11)	2004-12-14	0000-00-00	No	No	Current
0228-2636-50	00228263650	500 TABLET, FILM COATED in 1 BOTTLE (0228-2636-50)	2004-12-14	0000-00-00	No	No	Current
0228-2636-77	00228263677	17148 TABLET, FILM COATED in 1 CONTAINER (0228-2636-77)	17-JAN-24				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Actavis Pharma, Inc.	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL	36
GABAPENTIN TABLETS, USP	Proficient Rx	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	2
Gabapentin	NCS HealthCare of KY, Inc dba Vangard Labs	2015-10-28	HUMAN PRESCRIPTION DRUG LABEL	5