Gabapentin

Product NDC: 17856-0600
Requested package NDC: 17856-0600-2
11-digit product format: 178560600
Labeler code: 17856
Product ID: 17856-0600_361f9f34-f186-da49-e063-6394a90a3d51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gabapentin
Dosage form: SOLUTION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA076403
Marketing category: ANDA
Marketing start: 2018-06-29
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

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 1 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0600	17856-0600-2	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 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	A076403-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2012-05-01	`caaa826d4ba7…`
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…`

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	A076403-001	AA	1	`caaa826d4ba7…`
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…`

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
5969f1a8-d6d5-4967-add5-4e2492354d7b	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
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
17856-0600-1	2024-05-07	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
17856-0600-2	2024-05-07	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
17856-0600-7	2024-05-07	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
17856-0600-1	2024-01-30	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
17856-0600-2	2024-01-30	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
17856-0600-7	2024-01-30	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
17856-0600-1	2020-02-18	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
17856-0600-2	2020-02-18	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
17856-0600-1	2020-01-31	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
17856-0600-2	2020-01-31	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
17856-0600-1	Gabapentin	72 in 1 BOX	SOLUTION	72	7
17856-0600-2	Gabapentin	72 in 1 BOX	SOLUTION	72	7
17856-0600-3	Gabapentin	120 in 1 BOX, UNIT-DOSE	SOLUTION	120	7
17856-0600-4	Gabapentin	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	7
17856-0600-5	Gabapentin	6 mL in 1 CUP, UNIT-DOSE	SOLUTION	6	7
17856-0600-6	Gabapentin	2 mL in 1 SYRINGE	SOLUTION	2	7
17856-0600-7	Gabapentin	5 in 1 SYRINGE	SOLUTION	5	7
17856-0600-8	Gabapentin	60 in 1 BOX, UNIT-DOSE	SOLUTION	60	7
17856-0600-9	Gabapentin	2 mL in 1 SYRINGE	SOLUTION	2	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-0600-1	ML - Milliliter	17856-0600	247f9fe7-7bc3-4c3a-af79-da6efd4fc39b	1	2025-06-13
17856-0600-2	ML - Milliliter	17856-0600	1da3e4a4-4f69-4ef7-bf22-970e207c9796	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0600	GABAPENTIN SOLUTION [ATLANTIC BIOLOGICALS CORP.]	7	Current NDC, Legacy NDC, 9 package rows	20250529_5969f1a8-d6d5-4967-add5-4e2492354d7b.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 ndc (package): 17856-0600-2 ndc (product): 17856-0600 ndc11 (package): 17856060002

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	5969f1a8-d6d5-4967-add5-4e2492354d7b	7
283523	gabapentin 50 MG/ML Oral Solution	SCD	5969f1a8-d6d5-4967-add5-4e2492354d7b	7
283523	gabapentin 250 MG per 5 ML Oral Solution	SY	5969f1a8-d6d5-4967-add5-4e2492354d7b	7
283523	gabapentin 300 MG per 6 ML Oral Solution	SY	5969f1a8-d6d5-4967-add5-4e2492354d7b	7
283523	gabapentin 500 MG per 10 ML Oral Solution	SY	5969f1a8-d6d5-4967-add5-4e2492354d7b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0600-2	17856060002	72 CUP, UNIT-DOSE in 1 BOX (17856-0600-2) / 6 mL in 1 CUP, UNIT-DOSE (17856-0600-5)	2024-05-07	0000-00-00	No	No	Current