Gabapentin

Product NDC: 55700-686
11-digit product format: 557000686
Labeler code: 55700
Product ID: 55700-686_503fffe2-3a5a-4a34-8728-e0cc9f5b6c8b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA205101
Marketing category: ANDA
Marketing start: 2018-09-21
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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55700-686		D	Discontinued by firm	2026-10-05
excluded package	package	55700-686	55700-686-30	D	Discontinued by firm	2026-10-05
excluded package	package	55700-686	55700-686-60	D	Discontinued by firm	2026-10-05
excluded package	package	55700-686	55700-686-90	D	Discontinued by firm	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 · 57 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-686-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-686-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-686-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-686-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-686-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-686-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-686-90	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-686-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-686-60	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-686-90	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-686-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-686-60	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-686-90	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-686-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-686-60	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-686-90	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-686-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-686-60	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-686-90	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-686-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-686-60	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-686-90	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-686-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-686-60	D	Discontinued by firm	`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	55700-686-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-686-90	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-686-60	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	55700-686-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-686-90	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-686-60	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	55700-686-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-686-90	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-686-60	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	55700-686-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-686-90	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-686-60	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	55700-686-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55700-686-60	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	55700-686-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55700-686-60	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	55700-686-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-686-60	I	Inactivated by FDA	`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
A205101-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2016-02-04
A205101-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2016-02-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205101-001	AB1
A205101-002	AB1

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	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A205101-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205101-002	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205101-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205101-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205101-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205101-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205101-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205101-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205101-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205101-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205101-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205101-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205101-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205101-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205101-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205101-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205101-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205101-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
55700-686-30	2025-01-14	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
55700-686-60	2025-01-14	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
55700-686-90	2025-01-14	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
55700-686-30	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
55700-686-60	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
55700-686-90	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-686-30	EA - Each	55700-686	0f08d718-416f-4745-9549-a5aa62ed60b2	1	2018-10-11
55700-686-60	EA - Each	55700-686	54a34c06-9a65-4646-bf12-fee75c6556be	1	2018-10-11
55700-686-90	EA - Each	55700-686	fff7f5c1-00e8-4f1b-9128-2547b325337d	1	2018-10-11

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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	7a2aa696-7dac-4d03-916a-374b61a255b5	2024-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	79cd9dea-e7d0-44db-afba-964cb99f32b6	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	f9bf87e4-5499-4dd7-a0c1-16025a718d14	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Proficient Rx LP	9c96b488-19bd-431e-af9a-b313ffd9eaae	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	af62bb7e-162e-4e2a-8eb0-d50f66678707	2023-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Proficient Rx LP	35004f84-90ae-45f0-a2ba-653dec507229	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	9d544944-ea95-42e1-8c65-9e442437f0ee	2022-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	c18d9d06-f796-4eb7-8fd5-1de4ebb95439	2022-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Proficient Rx LP	b67b7865-df64-429a-9550-5333b9c713ea	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Proficient Rx LP	2fb2233f-9152-4630-ab39-51a0cda7e5ca	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Proficient Rx LP	2b76955c-52a4-4026-b286-3da1112fe989	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-686-30	55700068630	30 TABLET in 1 BOTTLE (55700-686-30)	30 tablet	2018-09-21	0000-00-00	No	No	Current
55700-686-60	55700068660	60 TABLET in 1 BOTTLE (55700-686-60)	60 tablet	2018-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Lake Erie Medical DBA Quality Care Products LLC	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	4