Gabapentin

Product NDC: 65862-523
Requested package NDC: 65862-523-29
11-digit product format: 658620523
Labeler code: 65862
Product ID: 65862-523_700d09f5-99cc-492d-ab49-442f674d9c5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA200651
Marketing category: ANDA
Marketing start: 2011-10-06
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

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
unfinished package	package	65862-523	65862-523-29	UNFINISHED	Active or certified unfinished drug listing		2026-08-07

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 · 18 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`

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
A200651-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2011-10-06
A200651-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2011-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200651-001	AB1
A200651-002	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	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-10-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-10-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-10-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-10-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-10-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-10-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200651-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-10-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200651-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-10-06	`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	A200651-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200651-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200651-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200651-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200651-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200651-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200651-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200651-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200651-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200651-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200651-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200651-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200651-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200651-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200651-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200651-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200651-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200651-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200651-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200651-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200651-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200651-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200651-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200651-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200651-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200651-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200651-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200651-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200651-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200651-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200651-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200651-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200651-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200651-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200651-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200651-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200651-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200651-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200651-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200651-002	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
25cf6c40-a239-4dd0-9cad-28da84d285db	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
65862-523-01	Gabapentin	100 in 1 BOTTLE	TABLET, FILM COATED	100	20
65862-523-05	Gabapentin	500 in 1 BOTTLE	TABLET, FILM COATED	500	20
65862-523-26	Gabapentin	2500 in 1 BOTTLE	TABLET, FILM COATED	2500	20
65862-523-90	Gabapentin	90 in 1 BOTTLE	TABLET, FILM COATED	90	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-523-01	EA - Each	65862-523	4db70288-66bf-4c15-8794-4a60f5344487	1	2012-07-24
65862-523-05	EA - Each	65862-523	19f1fd3d-2a88-402a-8008-11a69957b5b9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-523	GABAPENTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	20	Current NDC, Legacy NDC, 4 package rows	20250524_25cf6c40-a239-4dd0-9cad-28da84d285db.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	5a78ab50-993d-4857-be10-be665e02b353	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	429a1bb5-babf-4f36-8264-46d71164f1c0	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	7ddc7d92-9076-41cf-97ed-d9f9edc80298	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	b2da7d96-73ad-4f44-8784-160a384a0961	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Major Pharmaceuticals	152adf1d-ec0c-4561-bf80-e4c7da158723	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	A-S Medication Solutions	0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	A-S Medication Solutions	2343e3a1-82d0-4c70-a086-a01a0ce81ef3	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d9d78138-e1e9-4107-9099-4910cb1422d8	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	be9a572d-e98a-41c1-83c5-859d9176dd1c	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	8f982b95-4e84-4e0c-a543-747bc3dd7531	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d0510d04-460c-47d1-be72-0ee32c4ac640	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	NorthStar Rx LLC	9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	QUALLENT PHARMACEUTICALS HEALTH LLC	472bb279-bb4e-4246-b2a3-172483ba356b	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Aurobindo Pharma Limited	25cf6c40-a239-4dd0-9cad-28da84d285db	2025-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651 ndc (product): 65862-523
GABAPENTIN	GABAPENTIN	DIRECT RX	a5b47f89-ed35-31de-e053-2a95a90a5554	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afa28969-91c8-83fd-e053-2a95a90a656b	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b37b1dcc-c7e9-8845-e053-2995a90a089e	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c898711b-9a65-1816-e053-2995a90a855e	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651
Gabapentin	GABAPENTIN	Proficient Rx LP	c79d94ec-117d-4fb6-845d-1954e3472bb0	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200651 application number: ANDA200651

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	25cf6c40-a239-4dd0-9cad-28da84d285db	20
310434	gabapentin 800 MG Oral Tablet	PSN	25cf6c40-a239-4dd0-9cad-28da84d285db	20
310433	gabapentin 600 MG Oral Tablet	SCD	25cf6c40-a239-4dd0-9cad-28da84d285db	20
310434	gabapentin 800 MG Oral Tablet	SCD	25cf6c40-a239-4dd0-9cad-28da84d285db	20
310433	gabapentin 600 MG Oral Tablet	PSN	7ddc7d92-9076-41cf-97ed-d9f9edc80298	17
310433	gabapentin 600 MG Oral Tablet	SCD	7ddc7d92-9076-41cf-97ed-d9f9edc80298	17
310433	gabapentin 600 MG Oral Tablet	PSN	5a78ab50-993d-4857-be10-be665e02b353	13
310433	gabapentin 600 MG Oral Tablet	SCD	5a78ab50-993d-4857-be10-be665e02b353	13
310433	gabapentin 600 MG Oral Tablet	PSN	b37b1dcc-c7e9-8845-e053-2995a90a089e	9
310433	gabapentin 600 MG Oral Tablet	SCD	b37b1dcc-c7e9-8845-e053-2995a90a089e	9
310433	gabapentin 600 MG Oral Tablet	PSN	152adf1d-ec0c-4561-bf80-e4c7da158723	8
310434	gabapentin 800 MG Oral Tablet	PSN	152adf1d-ec0c-4561-bf80-e4c7da158723	8
310433	gabapentin 600 MG Oral Tablet	SCD	152adf1d-ec0c-4561-bf80-e4c7da158723	8
310434	gabapentin 800 MG Oral Tablet	SCD	152adf1d-ec0c-4561-bf80-e4c7da158723	8
310433	gabapentin 600 MG Oral Tablet	PSN	41f1e929-7c1f-4b3e-b142-4b7533300ee2	3
310434	gabapentin 800 MG Oral Tablet	PSN	41f1e929-7c1f-4b3e-b142-4b7533300ee2	3
310433	gabapentin 600 MG Oral Tablet	SCD	41f1e929-7c1f-4b3e-b142-4b7533300ee2	3
310434	gabapentin 800 MG Oral Tablet	SCD	41f1e929-7c1f-4b3e-b142-4b7533300ee2	3
310433	gabapentin 600 MG Oral Tablet	PSN	8f982b95-4e84-4e0c-a543-747bc3dd7531	1
310433	gabapentin 600 MG Oral Tablet	PSN	d0510d04-460c-47d1-be72-0ee32c4ac640	1
310433	gabapentin 600 MG Oral Tablet	SCD	8f982b95-4e84-4e0c-a543-747bc3dd7531	1
310433	gabapentin 600 MG Oral Tablet	SCD	d0510d04-460c-47d1-be72-0ee32c4ac640	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
65862-523-29	65862052329	20000 TABLET, FILM COATED in 1 BAG (65862-523-29)	07-MAY-20	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	REMEDYREPACK INC.	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	14
Gabapentin	REMEDYREPACK INC.	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	18
Gabapentin	Major Pharmaceuticals	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	8
Gabapentin	Bryant Ranch Prepack	2025-09-26	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	Bryant Ranch Prepack	2025-09-26	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	Aurobindo Pharma Limited \| Aurolife Pharma LLC \| APL HEALTHCARE LIMITED	2025-05-09	Human Prescription Drug Label	20
Gabapentin Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	9
Gabapentin	Bryant Ranch Prepack	2021-11-22	Human Prescription Drug Label	9
Gabapentin	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-03-30	HUMAN PRESCRIPTION DRUG LABEL	1
Gabapentin	Mylan Institutional Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	9
Gabapentin Tablets, USP	Aidarex Pharmaceuticals LLC	2012-09-26	HUMAN PRESCRIPTION DRUG LABEL	3