Gabapentin

Product NDC: 68071-1292
11-digit product format: 680711292
Labeler code: 68071
Product ID: 68071-1292_bb04dd0d-7dfc-15be-e053-2995a90a037e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA077662
Marketing category: ANDA
Marketing start: 2006-04-01
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-1292		D	Discontinued by firm	2026-09-14
excluded package	package	68071-1292	68071-1292-2	D	Discontinued by firm	2026-09-14
excluded package	package	68071-1292	68071-1292-3	D	Discontinued by firm	2026-09-14
excluded package	package	68071-1292	68071-1292-4	D	Discontinued by firm	2026-09-14
excluded package	package	68071-1292	68071-1292-6	D	Discontinued by firm	2026-09-14
excluded package	package	68071-1292	68071-1292-7	D	Discontinued by firm	2026-09-14
excluded package	package	68071-1292	68071-1292-8	D	Discontinued by firm	2026-09-14
excluded package	package	68071-1292	68071-1292-9	D	Discontinued by firm	2026-09-14

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 · 120 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	68071-1292-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1292-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1292-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1292-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1292-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1292-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1292-6	`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	68071-1292-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1292-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1292-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1292-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1292-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1292-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1292-6	`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	68071-1292-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1292-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1292-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1292-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1292-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1292-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1292-6	`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	68071-1292-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1292-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1292-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1292-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1292-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1292-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1292-6	`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	68071-1292-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1292-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1292-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1292-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1292-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1292-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1292-6	`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	68071-1292-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1292-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1292-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1292-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1292-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1292-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1292-6	`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	68071-1292-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1292-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1292-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1292-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1292-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1292-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1292-6	`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	68071-1292-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-1292-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-1292-9	`ed331223b511…`	`672a5bd82f5f…`

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
A077662-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2006-08-18
A077662-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2006-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077662-001	AB1
A077662-002	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	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`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	A077662-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077662-002	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077662-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077662-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077662-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077662-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077662-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077662-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077662-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077662-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077662-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077662-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077662-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077662-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077662-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077662-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077662-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077662-002	AB	1	`74a2ff9319b5…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-1292-2	2024-05-28	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-3	2024-05-28	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-4	2024-05-28	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-6	2024-05-28	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-7	2024-05-28	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-8	2024-05-28	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-9	2024-05-28	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-2	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 Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-3	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 Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-4	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 Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-6	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 Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-7	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 Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-8	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 Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-9	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 Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-2	2021-02-10	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-3	2021-02-10	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-4	2021-02-10	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-6	2021-02-10	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-7	2021-02-10	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-8	2021-02-10	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-9	2021-02-10	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-2	2021-01-29	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-3	2021-01-29	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-4	2021-01-29	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-6	2021-01-29	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-7	2021-01-29	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-8	2021-01-29	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993
68071-1292-9	2021-01-29	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN Tablets USP, for oral use Initial U.S. Approval: 1993

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	b7f9a106-52c6-49e4-acf5-8fb07761ba4f	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Coupler LLC	583ab038-7b6e-96f8-e063-6294a90adf47	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54edd6f3-06c7-a0c7-e063-6394a90a8b4f	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	4cb26d6e-7963-4fe5-903e-ab5180545066	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	BluePoint Laboratories	3368bf70-d466-4765-b2b7-7fe967a8c2b7	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	632cb507-5675-2392-0460-b09c0dd14650	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Glenmark Pharmaceuticals Inc., USA	3865a6e3-112c-490c-82ac-35401336b16e	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	137b2b9a-9d42-48d0-913f-5dc146fb689a	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2278ce1b-1c19-4ad2-89c6-4530f7b78ea7	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	7c3b232a-3e9f-4249-9e5a-295482ee288a	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Proficient Rx LP	c78f528f-9192-4037-bfb9-ff5718ed26c5	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662

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
68071-1292-2	68071129202	120 TABLET in 1 BOTTLE (68071-1292-2)	120 tablet	2017-02-22	0000-00-00	No	No	Current
68071-1292-3	68071129203	30 TABLET in 1 BOTTLE (68071-1292-3)	30 tablet	2017-02-22	0000-00-00	No	No	Current
68071-1292-4	68071129204	14 TABLET in 1 BOTTLE (68071-1292-4)	14 tablet	2017-02-22	0000-00-00	No	No	Current
68071-1292-6	68071129206	60 TABLET in 1 BOTTLE (68071-1292-6)	60 tablet	2017-02-22	0000-00-00	No	No	Current
68071-1292-7	68071129207	7 TABLET in 1 BOTTLE (68071-1292-7)	7 tablet	2017-02-22	0000-00-00	No	No	Current
68071-1292-8	68071129208	84 TABLET in 1 BOTTLE (68071-1292-8)	84 tablet	2017-02-22	0000-00-00	No	No	Current
68071-1292-9	68071129209	90 TABLET in 1 BOTTLE (68071-1292-9)	90 tablet	2017-02-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	NuCare Pharmaceuticals, Inc. \| NuCare Pharmaceuticals,Inc.	2021-02-10	HUMAN PRESCRIPTION DRUG LABEL	3