Gabapentin

Product NDC: 43063-611
11-digit product format: 430630611
Labeler code: 43063
Product ID: 43063-611_509f536a-edf8-4baf-e063-6394a90a738d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA078926
Marketing category: ANDA
Marketing start: 2012-10-16
Substance: GABAPENTIN
Active strength: 800 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A078926-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2011-02-11
A078926-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2011-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078926-001	AB1
A078926-002	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	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2011-02-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2011-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`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	A078926-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078926-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078926-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078926-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078926-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078926-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078926-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078926-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078926-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078926-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078926-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078926-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078926-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078926-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078926-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078926-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078926-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078926-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078926-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078926-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078926-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078926-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078926-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078926-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078926-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078926-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078926-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078926-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078926-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078926-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078926-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078926-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078926-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078926-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078926-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078926-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078926-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078926-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078926-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078926-002	AB	1	`bb7c543d1eb4…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
d22ed424-f365-44ca-8ef9-a08255a90ae8	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
43063-611-60	Gabapentin	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60		21
43063-611-90	Gabapentin	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-611-60	EA - Each	43063-611	91bd9678-3508-40be-ae11-a5ba67629368	1	2025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-611	GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	20	Current NDC, Legacy NDC, 2 package rows	20250130_d22ed424-f365-44ca-8ef9-a08255a90ae8.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	eeb19a5a-b31d-4df8-9546-0b2b5eb5db07	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078926 application number: ANDA078926
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	d22ed424-f365-44ca-8ef9-a08255a90ae8	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078926 application number: ANDA078926 ndc (product): 43063-611
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	81774da8-cb1d-4c7d-8550-35396850d5ff	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078926 application number: ANDA078926
Gabapentin	GABAPENTIN	Zydus Pharmaceuticals USA Inc.	310ce005-5a24-489a-b23c-d42ab6a3bfed	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078926 application number: ANDA078926
Gabapentin	GABAPENTIN	American Health Packaging	765c7ce0-bbf5-4265-8ff0-1ba092c69865	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078926 application number: ANDA078926
Gabapentin	GABAPENTIN	Zydus Lifesciences Limited	b033c169-4943-4ad9-ace0-7e4a1f0dc100	2024-11-30		Exact identifier application applno (ANDA): 078926 application number: ANDA078926

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
310434	gabapentin 800 MG Oral Tablet	PSN	d22ed424-f365-44ca-8ef9-a08255a90ae8	21
310434	gabapentin 800 MG Oral Tablet	SCD	d22ed424-f365-44ca-8ef9-a08255a90ae8	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-611-60	43063061160	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-611-60)	2025-01-29		No	No	Current
43063-611-90	43063061190	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-611-90)	2015-05-04	0000-00-00	No	No	Current