Gabapentin

Product NDC: 60687-919
11-digit product format: 606870919
Labeler code: 60687
Product ID: 60687-919_4c0c82ce-f685-61fd-e063-6294a90a2cff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: SOLUTION
Route: ORAL
Labeler: American Health Packaging
Application: ANDA211330
Marketing category: ANDA
Marketing start: 2026-03-02
Substance: GABAPENTIN
Active strength: 250 mg/5mL
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A211330-001	GABAPENTIN	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA		2019-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211330-001	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.

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	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2019-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2019-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2019-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2019-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2019-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2019-12-03	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL		2019-12-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211330-001	GABAPENTIN	250MG/5ML	SOLUTION / ORAL	AA	2019-12-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211330-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211330-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211330-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211330-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211330-001	AA	1	`6a471c1ec25d…`
2019-12-14 00:12 UTC	2019-12	A211330-001	AA	1	`3f01610625f2…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211330-001	AA	1	`a50c72e98297…`

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: 2027-12-31

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
e00f5048-1a06-44f4-b244-aa2755f4be22	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60687-919-41	Gabapentin	6 mL in 1 CUP, UNIT-DOSE	SOLUTION	6	2
60687-919-47	Gabapentin	10 in 1 TRAY	SOLUTION	10	2
60687-919-87	Gabapentin	4 in 1 CASE	SOLUTION	4	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-919-41	ML - Milliliter	60687-919	1f5f4d83-e0bf-4280-91f1-4258f396cbf2	1	2026-03-17
60687-919-87	ML - Milliliter	60687-919	8cb354ae-1676-4fb7-8c61-14ae13c86d98	1	2026-03-17

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	American Health Packaging	e00f5048-1a06-44f4-b244-aa2755f4be22	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211330 application number: ANDA211330 ndc (product): 60687-919
Gabapentin	GABAPENTIN	PAI Holdings, LLC dba PAI Pharma	6d3fd1f9-c831-4262-af10-291838a53541	2025-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211330 application number: ANDA211330

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	e00f5048-1a06-44f4-b244-aa2755f4be22	2
283523	gabapentin 50 MG/ML Oral Solution	SCD	e00f5048-1a06-44f4-b244-aa2755f4be22	2
283523	gabapentin 250 MG per 5 ML Oral Solution	SY	e00f5048-1a06-44f4-b244-aa2755f4be22	2
283523	gabapentin 300 MG per 6 ML Oral Solution	SY	e00f5048-1a06-44f4-b244-aa2755f4be22	2
283523	gabapentin 500 MG per 10 ML Oral Solution	SY	e00f5048-1a06-44f4-b244-aa2755f4be22	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60687-919-41	60687091941	6 mL in 1 CUP, UNIT-DOSE	6 ml				Historical
60687-919-47	60687091947	10 in 1 TRAY					Historical
60687-919-87	60687091987	4 TRAY in 1 CASE (60687-919-87) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-919-47) / 6 mL in 1 CUP, UNIT-DOSE (60687-919-41)	4 tray	2026-03-02	No	No	Current