Gabapentin

Product NDC: 70166-751
11-digit product format: 701660751
Labeler code: 70166
Product ID: 70166-751_bc2e92e0-9ca3-1403-e053-2a95a90a8d78
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gabapentin
Dosage form: SOLUTION
Route: ORAL
Labeler: Lohxa
Application: ANDA076403
Marketing category: ANDA
Marketing start: 2012-10-01
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: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

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

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70166-751		I	Inactivated by FDA	2026-08-03
excluded package	package	70166-751	70166-751-02	D	Discontinued by firm	2026-08-03
excluded package	package	70166-751	70166-751-03	D	Discontinued by firm	2026-08-03
excluded package	package	70166-751	70166-751-04	D	Discontinued by firm	2026-08-03
excluded package	package	70166-751	70166-751-05	D	Discontinued by firm	2026-08-03
excluded package	package	70166-751	70166-751-06	D	Discontinued by firm	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 2 · 75 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 package	package	70166-751-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70166-751-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70166-751-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70166-751-06	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70166-751-02	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 package	package	70166-751-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70166-751-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70166-751-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70166-751-06	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70166-751-02	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 package	package	70166-751-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70166-751-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70166-751-03	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70166-751-06	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70166-751-02	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 package	package	70166-751-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70166-751-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70166-751-03	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70166-751-06	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70166-751-02	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 package	package	70166-751-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70166-751-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70166-751-03	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70166-751-06	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70166-751-02	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 package	package	70166-751-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70166-751-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70166-751-03	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70166-751-06	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70166-751-02	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 package	package	70166-751-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70166-751-04	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70166-751-03	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70166-751-06	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70166-751-02	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 package	package	70166-751-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70166-751-04	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70166-751-03	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70166-751-06	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70166-751-02	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 package	package	70166-751-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70166-751-04	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70166-751-03	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70166-751-06	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70166-751-02	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 package	package	70166-751-05	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70166-751-04	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70166-751-03	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70166-751-06	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70166-751-02	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`

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

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
A076403-001	GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA		2012-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076403-001	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 · 41 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	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A076403-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076403-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076403-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076403-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076403-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076403-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076403-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076403-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076403-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076403-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076403-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076403-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076403-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076403-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076403-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076403-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076403-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076403-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076403-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076403-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076403-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076403-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076403-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076403-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076403-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076403-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076403-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076403-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076403-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076403-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076403-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076403-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076403-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076403-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076403-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076403-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076403-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076403-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076403-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076403-001	AA	1	`cb3db0bc1861…`

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, Effective, Related label table
NDC	Effective	Related label
70166-751-02	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-03	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-04	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-05	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-06	2023-01-30	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-02	2021-02-25	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-03	2021-02-25	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-04	2021-02-25	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-05	2021-02-25	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-06	2021-02-25	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-02	2021-01-29	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-03	2021-01-29	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-04	2021-01-29	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-05	2021-01-29	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
70166-751-06	2021-01-29	These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70166-751-02	Gabapentin	30 in 1 BOX	SOLUTION	30	2
70166-751-02	Gabapentin	2 mL in 1 SYRINGE	SOLUTION	2	2
70166-751-03	Gabapentin	30 in 1 BOX	SOLUTION	30	2
70166-751-03	Gabapentin	3 mL in 1 SYRINGE	SOLUTION	3	2
70166-751-04	Gabapentin	4 mL in 1 SYRINGE	SOLUTION	4	2
70166-751-04	Gabapentin	30 in 1 BOX	SOLUTION	30	2
70166-751-05	Gabapentin	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	2
70166-751-05	Gabapentin	100 in 1 BOX	SOLUTION	100	2
70166-751-06	Gabapentin	100 in 1 BOX	SOLUTION	100	2
70166-751-06	Gabapentin	6 mL in 1 CUP, UNIT-DOSE	SOLUTION	6	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70166-751	GABAPENTIN SOLUTION [LOHXA]	2	Legacy NDC, 10 package rows	20210226_2b4d316c-1234-41d7-831d-645b3dd6e448.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Acella Pharmaceuticals, LLC	3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa2	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076403 application number: ANDA076403
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	5134369d-c7f6-4569-a425-d50e5a5d694f	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076403 application number: ANDA076403
Gabapentin	GABAPENTIN	ATLANTIC BIOLOGICALS CORP.	5969f1a8-d6d5-4967-add5-4e2492354d7b	2025-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076403 application number: ANDA076403

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	2b4d316c-1234-41d7-831d-645b3dd6e448	2
283523	gabapentin 50 MG/ML Oral Solution	SCD	2b4d316c-1234-41d7-831d-645b3dd6e448	2
283523	gabapentin 250 MG per 5 ML Oral Solution	SY	2b4d316c-1234-41d7-831d-645b3dd6e448	2
283523	gabapentin 300 MG per 6 ML Oral Solution	SY	2b4d316c-1234-41d7-831d-645b3dd6e448	2
283523	gabapentin 500 MG per 10 ML Oral Solution	SY	2b4d316c-1234-41d7-831d-645b3dd6e448	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
70166-751-02	70166075102	30 in 1 BOX		Historical
70166-751-03	70166075103	30 in 1 BOX		Historical
70166-751-04	70166075104	4 mL in 1 SYRINGE	4 ml	Historical
70166-751-05	70166075105	5 mL in 1 CUP, UNIT-DOSE	5 ml	Historical
70166-751-06	70166075106	100 in 1 BOX		Historical