Gabapentin

Product NDC: 53217-268
11-digit product format: 532170268
Labeler code: 53217
Product ID: 53217-268_8f7996d0-00fe-4d22-bcd0-077f9c1898b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA090858
Marketing category: ANDA
Marketing start: 2011-01-29
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 400 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53217-268		I	Inactivated by FDA	2026-08-03
excluded package	package	53217-268	53217-268-02	I	Inactivated by FDA	2026-08-03
excluded package	package	53217-268	53217-268-30	I	Inactivated by FDA	2026-08-03
excluded package	package	53217-268	53217-268-60	I	Inactivated by FDA	2026-08-03
excluded package	package	53217-268	53217-268-90	I	Inactivated by FDA	2026-08-03
excluded package	package	53217-268	53217-268-99	I	Inactivated by FDA	2026-08-03

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 3 · 132 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	53217-268-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-268-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-268-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-268-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-268-99	`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	53217-268-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-268-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-268-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-268-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-268-99	`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	53217-268-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-268-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-268-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-268-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-268-99	`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	53217-268-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-268-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-268-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-268-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-268-99	`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	53217-268-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-268-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-268-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-268-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-268-99	`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	53217-268-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-268-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-268-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-268-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-268-99	`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	53217-268-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-268-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-268-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-268-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-268-99	`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	53217-268-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-268-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-268-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-268-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-268-99	`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	53217-268-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-268-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-268-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-268-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-268-99	`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	53217-268-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-268-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-268-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-268-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-268-99	`ad56d346431e…`	`cc804d4bbf1e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090858-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17
A090858-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17
A090858-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090858-001	AB
A090858-002	AB
A090858-003	AB

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 4 · 123 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	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2010-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2010-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090858-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2010-12-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A090858-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090858-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090858-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090858-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090858-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090858-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090858-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090858-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090858-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090858-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090858-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090858-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090858-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090858-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090858-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090858-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090858-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090858-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090858-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090858-001	AB	1	`8072bd15b7f6…`

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
53217-268-02	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use Initial U.S. Approval: 1993
53217-268-30	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use Initial U.S. Approval: 1993
53217-268-60	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use Initial U.S. Approval: 1993
53217-268-90	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use Initial U.S. Approval: 1993
53217-268-99	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53217-268-02	Gabapentin	120 in 1 BOTTLE	CAPSULE	120	1
53217-268-30	Gabapentin	30 in 1 BOTTLE	CAPSULE	30	1
53217-268-60	Gabapentin	60 in 1 BOTTLE	CAPSULE	60	1
53217-268-90	Gabapentin	90 in 1 BOTTLE	CAPSULE	90	1
53217-268-99	Gabapentin	180 in 1 BOTTLE	CAPSULE	180	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-268-02	EA - Each	53217-268	d3b51bb6-e33c-423a-80f6-85354dfaa144	1	2017-05-03
53217-268-30	EA - Each	53217-268	84212ef5-2a20-4e75-9e0e-99477d3ed05a	1	2017-05-03
53217-268-60	EA - Each	53217-268	404f1f88-53ba-45eb-9b2c-5b8d15b60b22	1	2017-05-03
53217-268-90	EA - Each	53217-268	fdb4c262-f3b4-4283-a7f5-e7aa9ee01fc7	1	2017-05-03
53217-268-99	EA - Each	53217-268	05cce793-ca52-49c4-b94a-bf93f3c65f21	1	2017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-268	GABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 5 package rows	20170408_04a0c58c-dddf-462d-96e6-9317161ea496.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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Ascend Laboratories, LLC	722de2a9-38b3-4518-b262-ba0d1346d0ba	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a1006139-7dfc-4d87-a5a9-aeb380c32d24	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	896c7782-1137-454b-aaa6-28f42c7413ef	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6a0a75ac-e121-477b-a9d1-d11f588afc9d	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	7652adc6-1aad-4422-b85c-0c6b11c23b73	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	d06380d0-c894-427e-b13e-5a8f9eb86a34	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	78445dbf-c7cd-419f-a7be-72821e496628	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Major Pharmaceuticals	36f74fdf-0dae-47a0-a7ea-e64ac91cd88f	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	14d61caa-17ce-4fa2-90fb-1470f3864be8	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	552912b2-be59-0333-e063-6394a90a85c0	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	55292235-bf8f-46d0-e063-6294a90a91a5	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	3e633cd0-5ee8-4a05-bcfc-0a80209bf27f	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54ecc64b-f019-9fcb-e063-6294a90a00af	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	ddb3a54f-5224-4024-8804-b2a2f01d885e	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	41844c21-9e2a-4332-a8ff-9b71ae9032b0	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	A-S Medication Solutions	03031adf-d36b-45ec-944e-dfce5a5de91a	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	d4f21e97-5e55-44c9-9b31-5f79ac2eb512	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Major Pharmaceuticals	999f3685-2eac-467e-bed2-1d0c36aaf0ed	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	fce0c123-29d7-42bf-8c8d-8be1772e2d99	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afc83432-8fce-6d2a-e053-2a95a90ae73f	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090858 application number: ANDA090858

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
310432	gabapentin 400 MG Oral Capsule	PSN	04a0c58c-dddf-462d-96e6-9317161ea496	1
310432	gabapentin 400 MG Oral Capsule	SCD	04a0c58c-dddf-462d-96e6-9317161ea496	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-268-02	53217026802	120 in 1 BOTTLE	Historical
53217-268-30	53217026830	30 in 1 BOTTLE	Historical
53217-268-60	53217026860	60 in 1 BOTTLE	Historical
53217-268-90	53217026890	90 in 1 BOTTLE	Historical
53217-268-99	53217026899	180 in 1 BOTTLE	Historical