GABAPENTIN

Product NDC: 85509-1166
11-digit product format: 855091166
Labeler code: 85509
Product ID: 85509-1166_5a85e9fd-1488-9f38-e063-6394a90aace9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: PHOENIX RX LLC
Application: ANDA214957
Marketing category: ANDA
Marketing start: 2021-10-01
Substance: GABAPENTIN
Active strength: 600 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214957-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2021-10-01
A214957-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2021-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214957-001	AB1
A214957-002	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 2 · 70 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	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2021-10-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2021-10-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2021-10-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2021-10-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2021-10-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2021-10-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2021-10-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2021-10-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214957-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2021-10-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214957-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2021-10-01	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A214957-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214957-002	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214957-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214957-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214957-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214957-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214957-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214957-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214957-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214957-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214957-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214957-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214957-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214957-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214957-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214957-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214957-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214957-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214957-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214957-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214957-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214957-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214957-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214957-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214957-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214957-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214957-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214957-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214957-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214957-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214957-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214957-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214957-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214957-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214957-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214957-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214957-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214957-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214957-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214957-002	AB	1	`bb7c543d1eb4…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310433	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
5a85ea98-4211-54eb-e063-6294a90aff33	Available on FDA.report

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	PHOENIX RX LLC	5a85ea98-4211-54eb-e063-6294a90aff33	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957 ndc (product): 85509-1166
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	c9f0cceb-b24e-4526-b873-fedd877d6bc6	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	St. Mary's Medical Park Pharmacy	07f07d15-ee91-8c2a-e063-6394a90a4624	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	35da078b-0da0-4757-a6c4-a9144c37e8e1	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	38119f2e-33b3-4c3c-99b7-9335d8d280d4	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Coupler LLC	500ee820-0378-6fc9-e063-6394a90a109c	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	ST. MARY'S MEDICAL PARK PHARMACY	4ddc1342-5c83-f562-e063-6294a90a29ba	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	2e331641-ec26-4d76-b16b-a9863c767afe	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	60b46f6d-efbc-487a-b672-b20df8b44cc4	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Proficient Rx LP	da8438e1-755b-4195-baa7-464f3d9ee5bd	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Camber Pharmaceuticals, Inc.	9ead7825-d11b-4e00-8533-328d097b8f83	2025-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Exelan Pharmaceuticals, Inc.	a88edb00-2189-4c8d-9dd7-9fe1571775cc	2025-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	XLCare Pharmaceuticals, Inc.	707ed63a-67ca-4a62-9cbe-cdeb5c4ab506	2025-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
Gabapentin	GABAPENTIN	Direct_Rx	ed9c501c-24e4-da89-e053-2a95a90a64c6	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Proficient Rx LP	7fcce531-bf7c-43b6-bea9-8f0602842c53	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Coupler LLC	3133c863-d33b-c9d7-e063-6294a90ae898	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	febf610e-e088-4797-e053-6294a90a3eb5	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
Gabapentin	GABAPENTIN	Direct_Rx	fbc05ceb-2e69-3c37-e053-6394a90ac4f4	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957
GABAPENTIN	GABAPENTIN	Clinical Solutions Wholesale, LLC	934fefae-b895-427c-8798-4c5462b1ecc2	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214957 application number: ANDA214957

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85509-1166-3	85509116603	30 TABLET in 1 BOTTLE (85509-1166-3)	30 tablet	2026-09-02	No	No	Current
85509-1166-6	85509116606	60 TABLET in 1 BOTTLE (85509-1166-6)	60 tablet	2026-09-02	No	No	Current
85509-1166-9	85509116609	90 TABLET in 1 BOTTLE (85509-1166-9)	90 tablet	2026-09-02	No	No	Current