Gabapentin

Product NDC: 85534-0010
11-digit product format: 855340010
Labeler code: 85534
Product ID: 85534-0010_559f2fb7-7b06-ee1a-e063-6394a90a580e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: HAWAII REPACK, INC.
Application: ANDA205101
Marketing category: ANDA
Marketing start: 2016-02-04
Substance: GABAPENTIN
Active strength: 800 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
A205101-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2016-02-04
A205101-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2016-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205101-001	AB1
A205101-002	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 · 86 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	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2016-02-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2016-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205101-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2016-02-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205101-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2016-02-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A205101-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205101-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205101-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205101-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205101-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205101-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205101-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205101-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205101-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205101-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205101-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205101-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205101-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205101-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205101-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205101-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205101-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205101-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205101-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205101-002	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205101-001	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205101-002	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205101-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205101-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205101-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205101-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205101-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205101-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205101-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205101-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205101-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205101-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205101-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A205101-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205101-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A205101-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205101-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205101-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205101-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A205101-002	AB	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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GABAPENTIN	800 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
f6ff265b-569b-4f5c-8fdb-00b7ad4aac7c	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 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	9b175f8d-7667-4bfe-8bb5-fd7441eed456	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	f6ff265b-569b-4f5c-8fdb-00b7ad4aac7c	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101 ndc (product): 85534-0010
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	ba4d863d-be38-8cf5-e053-2995a90a69fb	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	c85ae572-9893-629e-e053-2995a90a23fc	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ce0f0d7f-da6d-47da-a4ed-fb8f72902412	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	abb56036-88df-4720-ba78-529971671545	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a75c9157-a1fc-44cc-89f8-c5a3742fb9ed	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d1aa4690-57b5-4a3e-ac12-85f777dbd05e	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	75caca13-1432-4c0d-8d45-f029b0b2d417	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	56378630-e7a7-4981-8212-8ea703a433d8	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Radha Pharmaceuticals, Inc.	1045db4e-4c76-4a0d-bf12-019bd96a8f59	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	ScieGen Pharmaceuticals, Inc.	5ab9c18b-9568-4dcb-90b0-252aef8f8dc2	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	5d3f27bf-3486-40fa-a4d3-5f0b2c6c0151	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	561f53d5-5301-42b3-b372-f3d49d642a2e	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Coupler LLC	3133fc78-dd7a-880c-e063-6394a90a89e1	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Directrx	d5c9dd2c-b8ee-1406-e053-2995a90a0287	2025-01-21	Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
GABAPENTIN	GABAPENTIN	DIRECT RX	a7e45e3f-e382-32ba-e053-2a95a90a2537	2025-01-17		Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	Creekwood Pharmaceuticals LLC	266ef369-0a56-f225-e063-6294a90a495e	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a9c99dfa-f54d-9207-e053-2995a90ad43b	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a9f0852e-0c58-ba22-e053-2995a90adfa0	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205101 application number: ANDA205101

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
85534-0010-0	85534001000	30 TABLET in 1 BOTTLE (85534-0010-0)	30 tablet	2026-07-02	No	No	Current
85534-0010-1	85534001001	60 TABLET in 1 BOTTLE (85534-0010-1)	60 tablet	2026-07-02	No	No	Current
85534-0010-2	85534001002	90 TABLET in 1 BOTTLE (85534-0010-2)	90 tablet	2026-07-02	No	No	Current
85534-0010-3	85534001003	120 TABLET in 1 BOTTLE (85534-0010-3)	120 tablet	2026-07-02	No	No	Current