Application 078926

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	TABLET;ORAL	600MG	No	No
002	GABAPENTIN	GABAPENTIN	TABLET;ORAL	800MG	No	No

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
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 · 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	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…`
2021-12-28 21:50 UTC	2021-12	A078926-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2011-02-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078926-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2011-02-11	`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	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…`
2021-12-28 21:50 UTC	2021-12	A078926-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078926-002	AB	1	`782e0a99824c…`

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 ndc (product): 55154-8193 ndc (product): 55154-8189
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 ndc (product): 72789-127
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 ndc (product): 68382-205 ndc (product): 68382-204
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 ndc (product): 60687-518 ndc (product): 60687-507
Gabapentin	GABAPENTIN	Zydus Lifesciences Limited	b033c169-4943-4ad9-ace0-7e4a1f0dc100	2024-11-30		Exact identifier application applno (ANDA): 078926 application number: ANDA078926 ndc (product): 65841-705 ndc (product): 65841-706

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 62 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-611	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-611	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-611	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-611	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-3912	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-3912	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-3915	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-3915	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
55154-7132	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7132	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7132	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7132	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7149	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7149	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7149	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-8189	Gabapentin	Gabapentin	Cardinal Health 107, LLC	ANDA	Current
55154-8189	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-8189	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-8193	Gabapentin	Gabapentin	Cardinal Health 107, LLC	ANDA	Current
55154-8193	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
60687-507	Gabapentin	Gabapentin	American Health Packaging	ANDA	Current
60687-507	Gabapentin	Gabapentin	American Health Packaging	ANDA	Current
60687-507	Gabapentin	Gabapentin	American Health Packaging	ANDA	Current
60687-507	Gabapentin	Gabapentin	American Health Packaging	ANDA	Current
60687-518	Gabapentin	Gabapentin	American Health Packaging	ANDA	Current
60687-518	Gabapentin	Gabapentin	American Health Packaging	ANDA	Current
60687-518	Gabapentin	Gabapentin	American Health Packaging	ANDA	Current
60687-518	Gabapentin	Gabapentin	American Health Packaging	ANDA	Current
61919-104	GABAPENTIN	GABAPENTIN	DIRECT RX	ANDA	Current
63739-560	Gabapentin	Gabapentin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-560	Gabapentin	Gabapentin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-560	Gabapentin	Gabapentin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-560	Gabapentin	Gabapentin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-560	Gabapentin	Gabapentin	McKesson Corporation	ANDA	Current
65841-705	Gabapentin	Gabapentin	Zydus Lifesciences Limited	ANDA	Current
65841-705	Gabapentin	Gabapentin	Cadila Healthcare Limited	ANDA	Current
65841-705	Gabapentin	Gabapentin	Cadila Healthcare Limited	ANDA	Current
65841-705	Gabapentin	Gabapentin	Cadila Healthcare Limited	ANDA	Current
65841-706	Gabapentin	Gabapentin	Zydus Lifesciences Limited	ANDA	Current
65841-706	Gabapentin	Gabapentin	Cadila Healthcare Limited	ANDA	Current
65841-706	Gabapentin	Gabapentin	Cadila Healthcare Limited	ANDA	Current
65841-706	Gabapentin	Gabapentin	Cadila Healthcare Limited	ANDA	Current
68001-006	Gabapentin	Gabapentin	BluePoint Laboratories	ANDA	Current
68001-006	Gabapentin	Gabapentin	BluePoint Laboratories	ANDA	Current
68001-007	Gabapentin	Gabapentin	BluePoint Laboratories	ANDA	Current
68001-007	Gabapentin	Gabapentin	BluePoint Laboratories	ANDA	Current
68084-797	Gabapentin	Gabapentin	American Health Packaging	ANDA	Current
68084-797	Gabapentin	Gabapentin	American Health Packaging	ANDA	Current
68084-802	Gabapentin	Gabapentin	American Health Packaging	ANDA	Current
68084-802	Gabapentin	Gabapentin	American Health Packaging	ANDA	Current
68382-204	Gabapentin	Gabapentin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-204	Gabapentin	Gabapentin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-204	Gabapentin	Gabapentin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-204	Gabapentin	Gabapentin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-205	Gabapentin	Gabapentin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-205	Gabapentin	Gabapentin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-205	Gabapentin	Gabapentin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-205	Gabapentin	Gabapentin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
72789-127	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-127	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-127	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-127	Gabapentin	Gabapentin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current