GABAPENTIN

Product NDC: 21695-058
11-digit product format: 216950058
Labeler code: 21695
Product ID: 21695-058_95ceac2d-ce96-4d9d-9fe6-893940f1decb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GABAPENTIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: ANDA077525
Marketing category: ANDA
Marketing start: 2006-08-24
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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-058		I	Inactivated by FDA	2026-10-05
excluded package	package	21695-058	21695-058-30	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-058	21695-058-60	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-058	21695-058-90	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 2 · 88 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	21695-058-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-058-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-058-30	`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	21695-058-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-058-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-058-30	`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	21695-058-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-058-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-058-30	`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	21695-058-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-058-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-058-30	`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	21695-058-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-058-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-058-30	`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	21695-058-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-058-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-058-30	`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	21695-058-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-058-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-058-30	`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	21695-058-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-058-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-058-30	`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	21695-058-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-058-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-058-30	`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	21695-058-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-058-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-058-30	`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	21695-058-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-058-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-058-30	`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	21695-058-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-058-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-058-30	`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	21695-058-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-058-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-058-30	`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	21695-058-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-058-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-058-30	`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	21695-058-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-058-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-058-30	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077525-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL			2006-08-24
A077525-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL			2006-08-24

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 · 86 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	A077525-001	GABAPENTIN	600MG	TABLET / ORAL		2006-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077525-002	GABAPENTIN	800MG	TABLET / ORAL		2006-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077525-001	GABAPENTIN	600MG	TABLET / ORAL		2006-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077525-002	GABAPENTIN	800MG	TABLET / ORAL		2006-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077525-001	GABAPENTIN	600MG	TABLET / ORAL		2006-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077525-002	GABAPENTIN	800MG	TABLET / ORAL		2006-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077525-001	GABAPENTIN	600MG	TABLET / ORAL		2006-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077525-002	GABAPENTIN	800MG	TABLET / ORAL		2006-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077525-001	GABAPENTIN	600MG	TABLET / ORAL		2006-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077525-002	GABAPENTIN	800MG	TABLET / ORAL		2006-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077525-001	GABAPENTIN	600MG	TABLET / ORAL		2006-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077525-002	GABAPENTIN	800MG	TABLET / ORAL		2006-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077525-001	GABAPENTIN	600MG	TABLET / ORAL		2006-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077525-002	GABAPENTIN	800MG	TABLET / ORAL		2006-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077525-001	GABAPENTIN	600MG	TABLET / ORAL		2006-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077525-002	GABAPENTIN	800MG	TABLET / ORAL		2006-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077525-001	GABAPENTIN	600MG	TABLET / ORAL		2006-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077525-002	GABAPENTIN	800MG	TABLET / ORAL		2006-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077525-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077525-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077525-001	GABAPENTIN	600MG	TABLET / ORAL		2006-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077525-002	GABAPENTIN	800MG	TABLET / ORAL		2006-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077525-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077525-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077525-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077525-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077525-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077525-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077525-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077525-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077525-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077525-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077525-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077525-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077525-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077525-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077525-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077525-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077525-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077525-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077525-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077525-002	AB1	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	A077525-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077525-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077525-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077525-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077525-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077525-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077525-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077525-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077525-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077525-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077525-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077525-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077525-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077525-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077525-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077525-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077525-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077525-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077525-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077525-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077525-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077525-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077525-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077525-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077525-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077525-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077525-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077525-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077525-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077525-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077525-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077525-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077525-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077525-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077525-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077525-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077525-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077525-002	AB1	1	`6a51e52b5d6a…`

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-058-30	2019-09-24	C162847	48780-1	934fe258-49a4-48b1-e053-8cdaa90a720a	Gabapentin Tablets, USP
21695-058-60	2019-09-24	C162847	48780-1	934fe258-49a4-48b1-e053-8cdaa90a720a	Gabapentin Tablets, USP
21695-058-90	2019-09-24	C162847	48780-1	934fe258-49a4-48b1-e053-8cdaa90a720a	Gabapentin Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-058-30	GABAPENTIN	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
21695-058-60	GABAPENTIN	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
21695-058-90	GABAPENTIN	90 in 1 BOTTLE	TABLET, FILM COATED	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-058-30	EA - Each	21695-058	852110a5-7084-4458-b288-9a5528872c6d	1	2012-07-24
21695-058-60	EA - Each	21695-058	29677d3a-f225-411e-b132-17b426f9ebeb	1	2012-07-24
21695-058-90	EA - Each	21695-058	95bd8868-228b-47f7-8f0a-55c12892b60c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-058	GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 3 package rows	20091208_2fe659eb-a8b4-491b-9195-fe979d7f0373.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
gabapentin	GABAPENTIN	Sun Pharmaceutical Industries, Inc.	c9a05f0c-b5f0-422c-9d67-6d0efc921a74	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077525 application number: ANDA077525
gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	7790d906-af26-4e60-bc6f-e906ec03cc24	2022-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077525 application number: ANDA077525

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
310433	gabapentin 600 MG Oral Tablet	PSN	2fe659eb-a8b4-491b-9195-fe979d7f0373	1
310434	gabapentin 800 MG Oral Tablet	PSN	2fe659eb-a8b4-491b-9195-fe979d7f0373	1
310433	gabapentin 600 MG Oral Tablet	SCD	2fe659eb-a8b4-491b-9195-fe979d7f0373	1
310434	gabapentin 800 MG Oral Tablet	SCD	2fe659eb-a8b4-491b-9195-fe979d7f0373	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-058-30	21695005830	30 in 1 BOTTLE	Historical
21695-058-60	21695005860	60 in 1 BOTTLE	Historical
21695-058-90	21695005890	90 in 1 BOTTLE	Historical