Gabapentin

Product NDC: 80425-0201
11-digit product format: 804250201
Labeler code: 80425
Product ID: 80425-0201_2a99e9e8-3d19-ee0b-e063-6294a90ae4ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA207057
Marketing category: ANDA
Marketing start: 2022-10-28
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 1.

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
A207057-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2017-10-26
A207057-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2017-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207057-001	AB1
A207057-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207057-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207057-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207057-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207057-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207057-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207057-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207057-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207057-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207057-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207057-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207057-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207057-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207057-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207057-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207057-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207057-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207057-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207057-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207057-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207057-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207057-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207057-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207057-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207057-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207057-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207057-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207057-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207057-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207057-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207057-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207057-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207057-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207057-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207057-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207057-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207057-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207057-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207057-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207057-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207057-002	AB	1	`782e0a99824c…`

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
ec1a01fe-5531-21df-e053-2a95a90a0561	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
80425-0201-1	Gabapentin	30 in 1 BOTTLE	TABLET, COATED	30	9
80425-0201-2	Gabapentin	60 in 1 BOTTLE	TABLET, COATED	60	9
80425-0201-3	Gabapentin	90 in 1 BOTTLE	TABLET, COATED	90	9
80425-0201-4	Gabapentin	120 in 1 BOTTLE	TABLET, COATED	120	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0201-1	EA - Each	80425-0201	90a1afc9-7b07-4b59-9c12-87d7bea3700b	1	2023-04-07
80425-0201-2	EA - Each	80425-0201	a9b1742c-0867-40f0-8ab0-c35c01419c71	1	2023-04-07
80425-0201-3	EA - Each	80425-0201	e872ce0b-c49c-46b8-ba84-bbe5a4079e5e	1	2023-04-07
80425-0201-4	EA - Each	80425-0201	8aef4af8-da6e-491d-b8f9-311953f60f27	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0201	GABAPENTIN TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC]	9	Current NDC, Legacy NDC, 4 package rows	20250101_ec1a01fe-5531-21df-e053-2a95a90a0561.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	TAGI Pharma, Inc.	725878fa-1e2f-4fee-a9e1-a6e102c79625	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d8604417-9d43-4d27-a7ce-d4120ff201f4	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	A-S Medication Solutions	b88b0cbc-c883-4d17-8f46-0e5bddc57835	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	A-S Medication Solutions	081fd1de-acaa-4685-a053-4959d77b17e9	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Precision Dose, Inc.	021329d0-7d32-4fd8-81bf-a8b0d8b49e43	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	A-S Medication Solutions	b74a427c-9cc1-4b15-9ed2-cc891741fe67	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Mullan Pharmaceutical Inc.	47a22de2-ec66-45be-8648-89ed3ab6e67e	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Precision Dose, Inc.	86c93d8b-6286-44e2-93dd-f1b10a5d83da	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Proficient Rx LP	87b9171b-7d00-40fa-87ff-a717740efe8a	2025-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Proficient Rx LP	0ad67a07-59d0-4aaa-906b-befbbad8af31	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	07871ab8-254b-e3c2-e063-6294a90a29ab	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	2c65253d-ca49-70eb-e063-6394a90a3cd2	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	AvPAK	faa47fcd-2545-a946-e053-6294a90a05d2	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	ec1a01fe-5531-21df-e053-2a95a90a0561	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057 ndc (product): 80425-0201
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	2eec52a1-9016-46dd-8b4c-8dab1d0aeece	2024-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057

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	ec1a01fe-5531-21df-e053-2a95a90a0561	9
310434	gabapentin 800 MG Oral Tablet	PSN	ec1a01fe-5531-21df-e053-2a95a90a0561	9
310433	gabapentin 600 MG Oral Tablet	SCD	ec1a01fe-5531-21df-e053-2a95a90a0561	9
310434	gabapentin 800 MG Oral Tablet	SCD	ec1a01fe-5531-21df-e053-2a95a90a0561	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80425-0201-1	80425020101	30 TABLET, COATED in 1 BOTTLE (80425-0201-1)	2022-10-28	No	No	Current
80425-0201-2	80425020102	60 TABLET, COATED in 1 BOTTLE (80425-0201-2)	2022-10-28	No	No	Current
80425-0201-3	80425020103	90 TABLET, COATED in 1 BOTTLE (80425-0201-3)	2022-10-28	No	No	Current
80425-0201-4	80425020104	120 TABLET, COATED in 1 BOTTLE (80425-0201-4)	2022-10-28	No	No	Current