Gabapentin

Product NDC: 33261-051
11-digit product format: 332610051
Labeler code: 33261
Product ID: 33261-051_0756b645-0741-4473-b777-7ee472358140
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA200651
Marketing category: ANDA
Marketing start: 2011-10-06
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: 2019-12-31
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 · 14 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33261-051		I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-00	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-02	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-10	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-20	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-21	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-30	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-42	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-45	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-60	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-81	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-90	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-97	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-051	33261-051-99	I	Inactivated by FDA	2026-08-07

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 5 · 294 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	33261-051-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-051-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-051-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-051-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-051-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-051-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-051-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-051-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-051-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-051-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-051-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-051-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-051-10	`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	33261-051-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-051-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-051-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-051-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-051-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-051-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-051-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-051-97	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-051-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-051-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-051-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-051-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-051-10	`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	33261-051-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-051-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-051-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-051-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-051-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-051-81	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-051-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-051-97	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-051-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-051-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-051-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-051-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-051-10	`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	33261-051-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-051-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-051-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-051-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-051-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-051-81	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-051-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-051-97	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-051-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-051-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-051-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-051-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-051-10	`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	33261-051-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-051-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-051-90	`cfe11265f3b6…`	`090c488252e2…`

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
A200651-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2011-10-06
A200651-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2011-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200651-001	AB1
A200651-002	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 · 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	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-10-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-10-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-10-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-10-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-10-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-10-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-10-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200651-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200651-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200651-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200651-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200651-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200651-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200651-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200651-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200651-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200651-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200651-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200651-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200651-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200651-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200651-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200651-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200651-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200651-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200651-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200651-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200651-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200651-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200651-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200651-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200651-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200651-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200651-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200651-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200651-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200651-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200651-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200651-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200651-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200651-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200651-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200651-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200651-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200651-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200651-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200651-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cdc2ae60-922e-452d-a42f-787fe4e2ed06	Product name	1	20250123
7059096a-4b9f-36c2-db50-bb5c723e6e9e	Product name	2	20250114
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
33261-051-00	Gabapentin Tablets, USP
33261-051-02	Gabapentin Tablets, USP
33261-051-10	Gabapentin Tablets, USP
33261-051-20	Gabapentin Tablets, USP
33261-051-21	Gabapentin Tablets, USP
33261-051-30	Gabapentin Tablets, USP
33261-051-42	Gabapentin Tablets, USP
33261-051-45	Gabapentin Tablets, USP
33261-051-60	Gabapentin Tablets, USP
33261-051-81	Gabapentin Tablets, USP
33261-051-90	Gabapentin Tablets, USP
33261-051-97	Gabapentin Tablets, USP
33261-051-99	Gabapentin Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33261-051-00	Gabapentin	100 in 1 BOTTLE	TABLET, FILM COATED	100	3
33261-051-02	Gabapentin	120 in 1 BOTTLE	TABLET, FILM COATED	120	3
33261-051-10	Gabapentin	10 in 1 BOTTLE	TABLET, FILM COATED	10	3
33261-051-20	Gabapentin	20 in 1 BOTTLE	TABLET, FILM COATED	20	3
33261-051-21	Gabapentin	21 in 1 BOTTLE	TABLET, FILM COATED	21	3
33261-051-30	Gabapentin	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
33261-051-42	Gabapentin	42 in 1 BOTTLE	TABLET, FILM COATED	42	3
33261-051-45	Gabapentin	45 in 1 BOTTLE	TABLET, FILM COATED	45	3
33261-051-60	Gabapentin	60 in 1 BOTTLE	TABLET, FILM COATED	60	3
33261-051-81	Gabapentin	81 in 1 BOTTLE	TABLET, FILM COATED	81	3
33261-051-90	Gabapentin	90 in 1 BOTTLE	TABLET, FILM COATED	90	3
33261-051-97	Gabapentin	126 in 1 BOTTLE	TABLET, FILM COATED	126	3
33261-051-99	Gabapentin	180 in 1 BOTTLE	TABLET, FILM COATED	180	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-051-02	EA - Each	33261-051	30fe910c-f9ed-43b6-a29e-2c0432442ef9	1	2015-10-02
33261-051-10	EA - Each	33261-051	c60911a8-cf9f-4ab2-996f-5ac464c0ffc2	1	2015-10-02
33261-051-20	EA - Each	33261-051	78037f66-f102-4211-b9b4-83c59b953ed7	1	2015-10-02
33261-051-21	EA - Each	33261-051	9d71a9d1-38bc-427b-a078-bb8e6e478a75	1	2015-10-02
33261-051-30	EA - Each	33261-051	37f9036e-697e-45a0-a3d4-be2d91ffcad0	1	2015-10-02
33261-051-60	EA - Each	33261-051	b2d626bc-b13c-4eb1-9361-e51a85f47f92	1	2015-10-02
33261-051-90	EA - Each	33261-051	797cf2f9-bb6d-4e8b-bdff-090a4f9afeee	1	2015-10-02
33261-051-97	EA - Each	33261-051	23c6950f-7187-4d06-bc81-ab8f6271e6d8	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-051	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3	Legacy NDC, 13 package rows	20120927_41f1e929-7c1f-4b3e-b142-4b7533300ee2.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	5a78ab50-993d-4857-be10-be665e02b353	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	429a1bb5-babf-4f36-8264-46d71164f1c0	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	7ddc7d92-9076-41cf-97ed-d9f9edc80298	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	b2da7d96-73ad-4f44-8784-160a384a0961	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Major Pharmaceuticals	152adf1d-ec0c-4561-bf80-e4c7da158723	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	A-S Medication Solutions	0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	A-S Medication Solutions	2343e3a1-82d0-4c70-a086-a01a0ce81ef3	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d9d78138-e1e9-4107-9099-4910cb1422d8	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	be9a572d-e98a-41c1-83c5-859d9176dd1c	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	8f982b95-4e84-4e0c-a543-747bc3dd7531	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d0510d04-460c-47d1-be72-0ee32c4ac640	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	NorthStar Rx LLC	9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	QUALLENT PHARMACEUTICALS HEALTH LLC	472bb279-bb4e-4246-b2a3-172483ba356b	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Aurobindo Pharma Limited	25cf6c40-a239-4dd0-9cad-28da84d285db	2025-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
GABAPENTIN	GABAPENTIN	DIRECT RX	a5b47f89-ed35-31de-e053-2a95a90a5554	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afa28969-91c8-83fd-e053-2a95a90a656b	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b37b1dcc-c7e9-8845-e053-2995a90a089e	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c898711b-9a65-1816-e053-2995a90a855e	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Proficient Rx LP	c79d94ec-117d-4fb6-845d-1954e3472bb0	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651

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	41f1e929-7c1f-4b3e-b142-4b7533300ee2	3
310434	gabapentin 800 MG Oral Tablet	PSN	41f1e929-7c1f-4b3e-b142-4b7533300ee2	3
310433	gabapentin 600 MG Oral Tablet	SCD	41f1e929-7c1f-4b3e-b142-4b7533300ee2	3
310434	gabapentin 800 MG Oral Tablet	SCD	41f1e929-7c1f-4b3e-b142-4b7533300ee2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-051-00	33261005100	100 in 1 BOTTLE	Historical
33261-051-02	33261005102	120 in 1 BOTTLE	Historical
33261-051-10	33261005110	10 in 1 BOTTLE	Historical
33261-051-20	33261005120	20 in 1 BOTTLE	Historical
33261-051-21	33261005121	21 in 1 BOTTLE	Historical
33261-051-30	33261005130	30 in 1 BOTTLE	Historical
33261-051-42	33261005142	42 in 1 BOTTLE	Historical
33261-051-45	33261005145	45 in 1 BOTTLE	Historical
33261-051-60	33261005160	60 in 1 BOTTLE	Historical
33261-051-81	33261005181	81 in 1 BOTTLE	Historical
33261-051-90	33261005190	90 in 1 BOTTLE	Historical
33261-051-97	33261005197	126 in 1 BOTTLE	Historical
33261-051-99	33261005199	180 in 1 BOTTLE	Historical