Gabapentin

Product NDC: 55154-3366
11-digit product format: 551543366
Labeler code: 55154
Product ID: 55154-3366_d77f0adf-67c7-4e93-ab4e-aac274ae381a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA200651
Marketing category: ANDA
Marketing start: 2011-10-06
Substance: GABAPENTIN
Active strength: 800 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
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: 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
b2da7d96-73ad-4f44-8784-160a384a0961	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
55154-3366-0	Gabapentin	10 in 1 BAG	TABLET, FILM COATED	10		7
55154-3366-0	Gabapentin	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-3366	GABAPENTIN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20250427_b2da7d96-73ad-4f44-8784-160a384a0961.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 ndc (product): 55154-3366
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
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	b2da7d96-73ad-4f44-8784-160a384a0961	7
310434	gabapentin 800 MG Oral Tablet	PSN	b2da7d96-73ad-4f44-8784-160a384a0961	7
310433	gabapentin 600 MG Oral Tablet	SCD	b2da7d96-73ad-4f44-8784-160a384a0961	7
310434	gabapentin 800 MG Oral Tablet	SCD	b2da7d96-73ad-4f44-8784-160a384a0961	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-3366-0	55154336600	10 BLISTER PACK in 1 BAG (55154-3366-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2011-10-06	0000-00-00	No	No	Current