Gabapentin

Product NDC: 51224-121
11-digit product format: 512240121
Labeler code: 51224
Product ID: 51224-121_001831ce-47e9-4d0e-9aa5-d566575c2267
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: TAGI Pharma, Inc.
Application: ANDA207057
Marketing category: ANDA
Marketing start: 2019-05-01
Marketing end: 2026-12-31
Substance: GABAPENTIN
Active strength: 800 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51224-121	51224-121-50	D	Discontinued by firm		2026-08-03

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

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
725878fa-1e2f-4fee-a9e1-a6e102c79625	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
51224-121-50	Gabapentin	100 in 1 BOTTLE	TABLET, COATED	100		6
51224-121-60	Gabapentin	500 in 1 BOTTLE	TABLET, COATED	500		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51224-121-50	EA - Each	51224-121	a6c15f78-be0d-43ac-a125-c27c2d31df2e	1	2019-08-06
51224-121-60	EA - Each	51224-121	4b753741-b22f-467c-ad8d-f925088dcaa0	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51224-121	GABAPENTIN TABLET, COATED [TAGI PHARMA, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20210903_725878fa-1e2f-4fee-a9e1-a6e102c79625.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 ndc (product): 51224-121
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
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	725878fa-1e2f-4fee-a9e1-a6e102c79625	6
310434	gabapentin 800 MG Oral Tablet	PSN	725878fa-1e2f-4fee-a9e1-a6e102c79625	6
310433	gabapentin 600 MG Oral Tablet	SCD	725878fa-1e2f-4fee-a9e1-a6e102c79625	6
310434	gabapentin 800 MG Oral Tablet	SCD	725878fa-1e2f-4fee-a9e1-a6e102c79625	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51224-121-50	51224012150	100 TABLET, COATED in 1 BOTTLE (51224-121-50)	2019-05-01	0000-00-00	No	No	Current
51224-121-60	51224012160	500 TABLET, COATED in 1 BOTTLE (51224-121-60)	2019-05-01	2026-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	TAGI Pharma, Inc. \| CSPC Ouyi Pharmaceutical Co., Ltd	2026-07-28	HUMAN PRESCRIPTION DRUG LABEL	7
Gabapentin	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	3