Gabapentin

Product NDC: 60687-507
11-digit product format: 606870507
Labeler code: 60687
Product ID: 60687-507_37dcca50-b1a8-24e7-e063-6394a90a8adf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA078926
Marketing category: ANDA
Marketing start: 2020-03-24
Substance: GABAPENTIN
Active strength: 600 mg/1
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078926-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2011-02-11
A078926-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2011-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078926-001	AB1
A078926-002	AB1

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 3 · 84 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	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A078926-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078926-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078926-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078926-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078926-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078926-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078926-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078926-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078926-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078926-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078926-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078926-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078926-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078926-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078926-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078926-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078926-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078926-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078926-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078926-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078926-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078926-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078926-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078926-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078926-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078926-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078926-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078926-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078926-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078926-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078926-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078926-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078926-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078926-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078926-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078926-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078926-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078926-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078926-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078926-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	600 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310433	Internal RxNorm lookup
310434	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
765c7ce0-bbf5-4265-8ff0-1ba092c69865	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	Strength	SPL version
60687-507-01	Gabapentin	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	100		6
60687-507-11	Gabapentin	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-507-01	EA - Each	60687-507	6faa79b7-f9e4-4a00-9984-2ca336fae936	1	2020-02-13
60687-507-11	EA - Each	60687-507	b5658512-6d9d-4bd1-b0fd-351977c8f625	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-507	GABAPENTIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5	Current NDC, Legacy NDC, 2 package rows	20240605_765c7ce0-bbf5-4265-8ff0-1ba092c69865.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	eeb19a5a-b31d-4df8-9546-0b2b5eb5db07	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078926 application number: ANDA078926
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	d22ed424-f365-44ca-8ef9-a08255a90ae8	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078926 application number: ANDA078926
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	81774da8-cb1d-4c7d-8550-35396850d5ff	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078926 application number: ANDA078926
Gabapentin	GABAPENTIN	Zydus Pharmaceuticals USA Inc.	310ce005-5a24-489a-b23c-d42ab6a3bfed	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078926 application number: ANDA078926
Gabapentin	GABAPENTIN	American Health Packaging	765c7ce0-bbf5-4265-8ff0-1ba092c69865	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078926 application number: ANDA078926 ndc (product): 60687-507
Gabapentin	GABAPENTIN	Zydus Lifesciences Limited	b033c169-4943-4ad9-ace0-7e4a1f0dc100	2024-11-30		Exact identifier application applno (ANDA): 078926 application number: ANDA078926

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
310433	gabapentin 600 MG Oral Tablet	PSN	eeb19a5a-b31d-4df8-9546-0b2b5eb5db07	8
310434	gabapentin 800 MG Oral Tablet	PSN	eeb19a5a-b31d-4df8-9546-0b2b5eb5db07	8
310433	gabapentin 600 MG Oral Tablet	SCD	eeb19a5a-b31d-4df8-9546-0b2b5eb5db07	8
310434	gabapentin 800 MG Oral Tablet	SCD	eeb19a5a-b31d-4df8-9546-0b2b5eb5db07	8
310433	gabapentin 600 MG Oral Tablet	PSN	765c7ce0-bbf5-4265-8ff0-1ba092c69865	6
310434	gabapentin 800 MG Oral Tablet	PSN	765c7ce0-bbf5-4265-8ff0-1ba092c69865	6
310433	gabapentin 600 MG Oral Tablet	SCD	765c7ce0-bbf5-4265-8ff0-1ba092c69865	6
310434	gabapentin 800 MG Oral Tablet	SCD	765c7ce0-bbf5-4265-8ff0-1ba092c69865	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-507-01	60687050701	100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-507-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-507-11)	100 blister pack	2020-03-24	0000-00-00	No	No	Current
60687-507-11	60687050711	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Cardinal Health 107, LLC	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	8
Gabapentin	American Health Packaging	2025-06-18	HUMAN PRESCRIPTION DRUG LABEL	6