Gabapentin

Product NDC: 43353-863
Requested package NDC: 43353-863-30
11-digit product format: 433530863
Labeler code: 43353
Product ID: 43353-863_19801231-00a9-4772-b3b1-9be1ac7c1b86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA078787
Marketing category: ANDA
Marketing start: 2008-01-31
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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
excluded package	package	43353-863	43353-863-30	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-863	43353-863-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-863	43353-863-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078787-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31
A078787-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31
A078787-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078787-001	AB
A078787-002	AB
A078787-003	AB

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 4 · 126 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	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A078787-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078787-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078787-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078787-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078787-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078787-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078787-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-863-30	EA - Each	43353-863	b89c61e0-f30e-4854-98de-67f537990b39	1	2014-07-02
43353-863-53	EA - Each	43353-863	65378558-e369-4ce1-81b7-0bcab17e907b	1	2017-11-06
43353-863-60	EA - Each	43353-863	5e590074-c98d-4ddc-8b65-619f3fb536eb	1	2017-11-06
43353-863-70	EA - Each	43353-863	b64e7041-d685-4332-9ed2-5a3893987c11	1	2014-07-02
43353-863-80	EA - Each	43353-863	3cd48073-bb0e-4416-9439-e144ea9a4451	1	2017-11-06
43353-863-92	EA - Each	43353-863	80f55fdd-9126-4d04-83e4-7cf51beda99c	1	2017-11-06
43353-863-94	EA - Each	43353-863	ce27a9e2-0470-4773-b6fb-819f479217c4	1	2014-07-02
43353-863-98	EA - Each	43353-863	98550c86-3469-412f-8129-a7c3887c5286	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GABAPENTIN	ACTIVE INGREDIENT	6CW7F3G59X	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
GABAPENTIN	ACTIVE MOIETY	6CW7F3G59X	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-863	GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC	20171029_f041f43e-dbd8-4cbf-ad77-f0d9c6b8ffa8.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Redpharm Drug	58474aa7-7c6a-3a94-e063-6394a90a870b	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	6beed8eb-446c-4575-8dc8-b798623d92c7	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	912d8697-b466-48dc-88d3-d2ba90e76644	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	3dbd447f-4791-4c62-86b4-6f7928862785	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	67330eef-c976-4862-b1ae-20f30f43df76	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	efb86e22-5a84-4b33-aad0-71dd5a2c6c8f	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	eaf5e41e-8ed3-404e-84e0-392bebdbc0b7	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	344d67fa-092e-4e71-b96a-25c71bfa6bb1	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	bc1316b6-1fc4-4990-95a8-489881772876	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	NorthStar Rx LLC	f7c1fd34-d615-43a2-8989-898fe11f90df	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	d25daaac-a8ab-4f12-acc2-4ec8fc97a2d4	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Aurobindo Pharma Limited	1a619a14-0b63-4cba-80e7-474c9a1c90b9	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b33c18ea-554d-3cfb-e053-2a95a90a2dd1	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	bc08e35d-ef5d-1dcd-e053-2a95a90ab5de	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ff28c5f1-da56-4072-a6fa-d689d4a6761b	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1e28ad3d-2d34-a5d0-e063-6294a90adb9e	2024-07-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	ecb798a0-377d-4712-bb82-ec9d7116962f	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	3b4395f2-9440-4b67-97cc-5d16f3bdd05e	2020-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Proficient Rx LP	ded42b88-94dd-462d-bcdf-7fd34d1e49c3	2020-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Proficient Rx LP	7d77dae0-df76-4b7b-9690-713e9a60e3cd	2019-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-863-30	43353086330	30 CAPSULE in 1 BOTTLE, PLASTIC (43353-863-30)	30 capsule	2013-12-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2017-10-26	Human Prescription Drug Label	3