Gabapentin

Product NDC: 45865-347
11-digit product format: 458650347
Labeler code: 45865
Product ID: 45865-347_62717c61-b047-49f2-ab29-a852dc5dead2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA078428
Marketing category: ANDA
Marketing start: 2009-11-24
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

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

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45865-347		I	Inactivated by FDA	2026-08-17
excluded package	package	45865-347	45865-347-30	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-347	45865-347-49	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-347	45865-347-57	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-347	45865-347-60	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-347	45865-347-90	I	Inactivated by FDA	2026-08-17

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	45865-347-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-347-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-347-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-347-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-347-49	`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	45865-347-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-347-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-347-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-347-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-347-49	`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	45865-347-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-347-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-347-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-347-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-347-49	`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	45865-347-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-347-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-347-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-347-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-347-49	`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	45865-347-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-347-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-347-57	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-347-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-347-49	`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	45865-347-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-347-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-347-57	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-347-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-347-49	`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	45865-347-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-347-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-347-57	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-347-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-347-49	`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	45865-347-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-347-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-347-57	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-347-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-347-49	`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	45865-347-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-347-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-347-57	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-347-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-347-49	`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	45865-347-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-347-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-347-57	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-347-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-347-49	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078428-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25
A078428-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25
A078428-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078428-001	AB
A078428-002	AB
A078428-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078428-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078428-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078428-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078428-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078428-001	AB	1	`1e350fbaab3a…`

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
45865-347-30	Gabapentin Capsules, USP
45865-347-49	Gabapentin Capsules, USP
45865-347-57	Gabapentin Capsules, USP
45865-347-60	Gabapentin Capsules, USP
45865-347-90	Gabapentin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
45865-347-30	Gabapentin	30 in 1 BOTTLE	CAPSULE	30	1
45865-347-49	Gabapentin	100 in 1 BOTTLE	CAPSULE	100	1
45865-347-57	Gabapentin	180 in 1 BOTTLE	CAPSULE	180	1
45865-347-60	Gabapentin	60 in 1 BOTTLE	CAPSULE	60	1
45865-347-90	Gabapentin	90 in 1 BOTTLE	CAPSULE	90	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-347	GABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 5 package rows	20120801_119ff7cc-5a38-490a-a982-7431b34d061c.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54dc347e-cba0-ea73-e063-6294a90ab436	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Amneal Pharmaceuticals LLC	507bf6d0-e7a2-413d-9848-cd2445a1411d	2026-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	7b404ab9-8a7e-49d4-920f-487875d14e45	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	657349fb-41a9-4814-b4ac-4c5afbdde947	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a15d5dcc-63c4-4c06-ab91-5e22cdf234cc	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	477691f5-0591-4544-840a-ac590e1f25a1	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	506bf880-9564-404c-951a-703797ffdad8	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	dbedccfb-0e27-4119-93b9-241c039e045a	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Amneal Pharmaceuticals of New York LLC	b11dbff5-ceee-4a63-a093-f6efebdc2f6f	2021-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428

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
310431	gabapentin 300 MG Oral Capsule	PSN	119ff7cc-5a38-490a-a982-7431b34d061c	1
310431	gabapentin 300 MG Oral Capsule	SCD	119ff7cc-5a38-490a-a982-7431b34d061c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
45865-347-30	45865034730	30 in 1 BOTTLE	Historical
45865-347-49	45865034749	100 in 1 BOTTLE	Historical
45865-347-57	45865034757	180 in 1 BOTTLE	Historical
45865-347-60	45865034760	60 in 1 BOTTLE	Historical
45865-347-90	45865034790	90 in 1 BOTTLE	Historical