Gabapentin

Product NDC: 50436-0428
Requested package NDC: 50436-0428-1
11-digit product format: 504360428
Labeler code: 50436
Product ID: 50436-0428_84223092-9dbf-48b8-8e19-3df49a142e3e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA206402
Marketing category: ANDA
Marketing start: 2015-11-01
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 600 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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	50436-0428	50436-0428-1	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A206402-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2015-12-23
A206402-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2015-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206402-001	AB1
A206402-002	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	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2015-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2015-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2015-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2015-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2015-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2015-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2015-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2015-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2015-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2015-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2015-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2015-12-23	`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	A206402-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206402-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206402-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206402-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206402-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206402-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206402-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206402-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206402-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206402-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206402-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206402-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206402-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206402-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206402-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206402-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206402-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206402-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206402-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206402-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206402-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206402-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206402-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206402-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206402-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206402-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206402-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206402-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206402-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206402-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206402-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206402-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206402-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206402-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206402-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206402-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206402-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206402-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206402-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206402-002	AB	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-0428-1	2023-01-30	C162847	48780-1	f386c64a-0206-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets,for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-0428-1	Gabapentin	90 in 1 BOTTLE	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-0428-1	EA - Each	50436-0428	4113e868-ba34-4dac-8166-1309385291ca	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0428	GABAPENTIN TABLET [UNIT DOSE SERVICES]	2	Legacy NDC, 1 package rows	20210318_2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	81243958-cc5a-4ec0-a64d-71682f949d5f	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	bc525ae4-9843-4038-a1b7-0d3543e2282c	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	57383d2a-d2c7-bbdc-e063-6294a90ada98	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	172776c0-909e-49ce-bfe1-cf154a9458ba	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	df9c7c84-a8d9-4da8-babe-c55c9420d4e6	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	72729513-bd34-44f5-9f62-297ed25c4442	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	f31172a2-0ae9-49f2-b797-b26fe33f3f64	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	Ascend Laboratories, LLC	4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	Direct_Rx	30a2ed14-dcda-f972-e063-6294a90a417c	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a1ff94a9-69c4-486a-aab2-563c7ed244c8	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afa28969-91ca-83fd-e053-2a95a90a656b	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402

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	2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d	2
310434	gabapentin 800 MG Oral Tablet	PSN	2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d	2
310433	gabapentin 600 MG Oral Tablet	SCD	2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d	2
310434	gabapentin 800 MG Oral Tablet	SCD	2f3bcce0-c2bd-4a2a-b35c-43bb4111d59d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-0428-1	50436042801	90 TABLET in 1 BOTTLE (50436-0428-1)	90 tablet	2021-03-17	0000-00-00	No	No	Current