Gabapentin

Product NDC: 82983-423
11-digit product format: 829830423
Labeler code: 82983
Product ID: 82983-423_1e85899c-edf0-49d0-a007-06f8e6655a43
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: SOLUTION
Route: ORAL
Labeler: Ajenat Pharmaceuticals LLC
Application: ANDA091286
Marketing category: ANDA
Marketing start: 2025-08-06
Substance: GABAPENTIN
Active strength: 250 mg/5mL
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091286-001	GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA		2016-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091286-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091286-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2016-03-14	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091286-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091286-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091286-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091286-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091286-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091286-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091286-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091286-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091286-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091286-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091286-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091286-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091286-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091286-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091286-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091286-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091286-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091286-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091286-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091286-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091286-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091286-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091286-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091286-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091286-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091286-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091286-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091286-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091286-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091286-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091286-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091286-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091286-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091286-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091286-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091286-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091286-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091286-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091286-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091286-001	AA	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Gabapentin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	250 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6CW7F3G59X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283523	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
02304deb-7b4a-452f-9b1a-64ca0aedbcc2	Available on FDA.report

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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82983-423-47	Gabapentin	473 mL in 1 BOTTLE	SOLUTION	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82983-423-47	ML - Milliliter	82983-423	a990d064-15ec-4f1a-a77b-fce66286b6ea	1	2025-12-16

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Ajenat Pharmaceuticals LLC	02304deb-7b4a-452f-9b1a-64ca0aedbcc2	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091286 application number: ANDA091286 ndc (product): 82983-423
Gabapentin	GABAPENTIN	JVET PHARMACEUTICALS LLC	63a5fc6d-ca57-4726-b70d-805ac023d959	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091286 application number: ANDA091286
Gabapentin	GABAPENTIN	Kesin Pharma Corporation	4470a567-93a6-a293-e063-6394a90affc1	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091286 application number: ANDA091286
Gabapentin	GABAPENTIN	Kesin Pharma Corporation	3f2ba3d6-6086-eaf2-e063-6294a90a7642	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091286 application number: ANDA091286

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	02304deb-7b4a-452f-9b1a-64ca0aedbcc2	2
283523	gabapentin 50 MG/ML Oral Solution	SCD	02304deb-7b4a-452f-9b1a-64ca0aedbcc2	2
283523	gabapentin 250 MG per 5 ML Oral Solution	SY	02304deb-7b4a-452f-9b1a-64ca0aedbcc2	2
283523	gabapentin 300 MG per 6 ML Oral Solution	SY	02304deb-7b4a-452f-9b1a-64ca0aedbcc2	2
283523	gabapentin 500 MG per 10 ML Oral Solution	SY	02304deb-7b4a-452f-9b1a-64ca0aedbcc2	2
283523	gabapentin 250 MG in 5 mL Oral Solution	PSN	3f2ba3d6-6086-eaf2-e063-6294a90a7642	1
283523	gabapentin 50 MG/ML Oral Solution	SCD	3f2ba3d6-6086-eaf2-e063-6294a90a7642	1
283523	gabapentin 250 MG per 5 ML Oral Solution	SY	3f2ba3d6-6086-eaf2-e063-6294a90a7642	1
283523	gabapentin 300 MG per 6 ML Oral Solution	SY	3f2ba3d6-6086-eaf2-e063-6294a90a7642	1
283523	gabapentin 500 MG per 10 ML Oral Solution	SY	3f2ba3d6-6086-eaf2-e063-6294a90a7642	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82983-423-47	82983042347	473 mL in 1 BOTTLE (82983-423-47)	473 ml	2025-08-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Ajenat Pharmaceuticals LLC	2025-12-29	HUMAN PRESCRIPTION DRUG LABEL	2
Gabapentin	Kesin Pharma Corporation	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	1