Gabapentin

Product NDC: 80425-0149
Requested package NDC: 80425-0149-3
11-digit product format: 804250149
Labeler code: 80425
Product ID: 80425-0149_ed11a31c-6509-35b6-e053-2995a90a768d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA075477
Marketing category: ANDA
Marketing start: 2020-01-01
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: 2023-12-31
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	80425-0149	80425-0149-3	D	Discontinued by firm		2026-08-07

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075477-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23
A075477-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23
A075477-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075477-001	AB
A075477-002	AB
A075477-003	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 · 123 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	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A075477-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075477-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075477-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075477-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075477-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075477-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075477-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075477-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075477-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075477-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075477-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075477-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075477-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0149-1	EA - Each	80425-0149	12384b4f-760f-4e5c-bae2-8417dce05556	1	2023-06-06
80425-0149-2	EA - Each	80425-0149	b82e548e-cfad-453c-b590-e3b471cf294f	1	2023-06-06
80425-0149-3	EA - Each	80425-0149	24ce66a3-bc7a-407a-b159-0c414667e9b4	1	2023-06-06

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Proficient Rx LP	9d401e54-d4f5-43ba-b898-dd08fc3c7bfa	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Mullan Pharmaceutical Inc.	74474aa4-4859-42d2-92d8-f23f18b34e04	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Proficient Rx LP	3c8dca11-78ab-45c1-8bb2-89a41ea5dfa9	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	3ad96553-73a4-4a9b-8a89-10a29b794ed3	2025-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	0919fed8-e968-b5ac-e063-6294a90afbff	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	ec1c621b-db2a-1567-e053-2995a90a8695	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	ebf57adf-b066-2959-e053-2a95a90a961c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	f781d400-7304-5d3e-e053-6294a90ac572	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477

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
80425-0149-3	80425014903	90 CAPSULE in 1 BOTTLE (80425-0149-3)	90 capsule	2020-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin 300mg Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2022-11-09	HUMAN PRESCRIPTION DRUG LABEL	6