Gabapentin

Product NDC: 17856-0311
11-digit product format: 178560311
Labeler code: 17856
Product ID: 17856-0311_a85eb3d4-e7d4-4a52-87fd-5d57e2732175
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: SOLUTION
Route: ORAL
Labeler: Atlantic Biologicals Corps
Application: ANDA078974
Marketing category: ANDA
Marketing start: 2011-02-23
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 250 mg/5mL
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-0311		D	Discontinued by firm	2026-09-09
excluded product	product	17856-0311		I	Inactivated by FDA	2026-09-09
excluded package	package	17856-0311	17856-0311-2	D	Discontinued by firm	2026-09-09
excluded package	package	17856-0311	17856-0311-2	I	Inactivated by FDA	2026-09-09
excluded package	package	17856-0311	17856-0311-3	I	Inactivated by FDA	2026-09-09

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 · 90 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0311-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0311-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0311-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0311-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0311-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0311-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0311-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0311-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0311-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0311-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0311-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0311-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0311-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0311-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0311-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0311-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0311-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0311-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0311-3	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0311-2	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0311-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0311-3	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0311-2	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0311-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0311-3	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0311-2	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0311-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0311-3	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0311-2	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0311-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0311-3	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0311-2	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0311-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0311-3	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0311-2	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0311-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078974-001	GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA		2011-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078974-001	AA

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 2 · 42 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	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078974-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2011-02-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A078974-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078974-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078974-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078974-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078974-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078974-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078974-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078974-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078974-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078974-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078974-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078974-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078974-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078974-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078974-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078974-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078974-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078974-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078974-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078974-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078974-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078974-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078974-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078974-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078974-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078974-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078974-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078974-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078974-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078974-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078974-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078974-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078974-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078974-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078974-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078974-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078974-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078974-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078974-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078974-001	AA	1	`e64feba35796…`

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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0311-2	2020-01-31	C162847	48780-1	9d75b9d0-4c2a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN oral solution Initial U.S. Approval: 1993
17856-0311-3	2020-01-31	C162847	48780-1	9d75b9d0-4c2a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN oral solution Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-0311-2	Gabapentin	6 mL in 1 CUP	SOLUTION	6		9
17856-0311-3	Gabapentin	6 mL in 1 CUP	SOLUTION	6		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0311	GABAPENTIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]	9	Legacy NDC, 2 package rows	20160909_31e18a2a-b43f-4b53-a51d-7479781bae7c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	BioComp Pharma, Inc.	0b3a4009-42f3-c84f-e063-6294a90a8068	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078974 application number: ANDA078974

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
283523	gabapentin 250 MG in 5 mL Oral Solution	PSN	31e18a2a-b43f-4b53-a51d-7479781bae7c	9
283523	gabapentin 50 MG/ML Oral Solution	SCD	31e18a2a-b43f-4b53-a51d-7479781bae7c	9
283523	gabapentin 250 MG per 5 ML Oral Solution	SY	31e18a2a-b43f-4b53-a51d-7479781bae7c	9
283523	gabapentin 300 MG per 6 ML Oral Solution	SY	31e18a2a-b43f-4b53-a51d-7479781bae7c	9
283523	gabapentin 500 MG per 10 ML Oral Solution	SY	31e18a2a-b43f-4b53-a51d-7479781bae7c	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
17856-0311-2	17856031102	6 mL in 1 CUP	6 ml	Historical
17856-0311-3	17856031103	6 mL in 1 CUP	6 ml	Historical