Gabapentin

Product NDC: 55289-959
11-digit product format: 552890959
Labeler code: 55289
Product ID: 55289-959_3892af8e-2138-00ac-e063-6394a90a516f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA077662
Marketing category: ANDA
Marketing start: 2006-04-01
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 42.

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
A077662-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2006-08-18
A077662-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2006-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077662-001	AB1
A077662-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077662-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077662-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077662-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077662-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077662-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077662-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077662-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077662-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077662-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077662-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077662-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077662-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077662-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077662-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077662-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077662-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077662-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077662-002	AB	1	`bb7c543d1eb4…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310433	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
7c3b232a-3e9f-4249-9e5a-295482ee288a	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
55289-959-30	Gabapentin	30 in 1 BOTTLE, PLASTIC	TABLET	30	26
55289-959-60	Gabapentin	60 in 1 BOTTLE, PLASTIC	TABLET	60	26
55289-959-90	Gabapentin	90 in 1 BOTTLE, PLASTIC	TABLET	90	26
55289-959-98	Gabapentin	120 in 1 BOTTLE, PLASTIC	TABLET	120	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-959-30	EA - Each	55289-959	962a9097-9f75-48dc-a90f-cb2f8c8b30a2	1	2020-04-20
55289-959-60	EA - Each	55289-959	a0525026-e3fe-4d6f-b853-6f06967b5102	1	2012-07-24
55289-959-90	EA - Each	55289-959	25a2d351-4734-40d1-b3ec-c4494ccbb43d	1	2012-07-24
55289-959-98	EA - Each	55289-959	6f85e8b5-17cf-4d94-be52-1ee1e71c9703	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	6
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	6
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	6
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	6
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55289-959	GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.]	25	Current NDC, Legacy NDC, 4 package rows	20250316_7c3b232a-3e9f-4249-9e5a-295482ee288a.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Coupler LLC	583ab038-7b6e-96f8-e063-6294a90adf47	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54edd6f3-06c7-a0c7-e063-6394a90a8b4f	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	4cb26d6e-7963-4fe5-903e-ab5180545066	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	BluePoint Laboratories	3368bf70-d466-4765-b2b7-7fe967a8c2b7	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	632cb507-5675-2392-0460-b09c0dd14650	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Glenmark Pharmaceuticals Inc., USA	3865a6e3-112c-490c-82ac-35401336b16e	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	137b2b9a-9d42-48d0-913f-5dc146fb689a	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2278ce1b-1c19-4ad2-89c6-4530f7b78ea7	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	7c3b232a-3e9f-4249-9e5a-295482ee288a	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662 ndc (product): 55289-959
Gabapentin	GABAPENTIN	Proficient Rx LP	c78f528f-9192-4037-bfb9-ff5718ed26c5	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662

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	7c3b232a-3e9f-4249-9e5a-295482ee288a	26
310433	gabapentin 600 MG Oral Tablet	SCD	7c3b232a-3e9f-4249-9e5a-295482ee288a	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-959-30	55289095930	30 TABLET in 1 BOTTLE, PLASTIC (55289-959-30)	30 tablet	2020-01-27	0000-00-00	No	No	Current
55289-959-60	55289095960	60 TABLET in 1 BOTTLE, PLASTIC (55289-959-60)	60 tablet	2011-10-10	0000-00-00	No	No	Current
55289-959-90	55289095990	90 TABLET in 1 BOTTLE, PLASTIC (55289-959-90)	90 tablet	2011-10-10	0000-00-00	No	No	Current
55289-959-98	55289095998	120 TABLET in 1 BOTTLE, PLASTIC (55289-959-98)	120 tablet	2011-10-10	0000-00-00	No	No	Current