Gabapentin

Product NDC: 67046-703
Requested package NDC: 67046-703-30
11-digit product format: 670460703
Labeler code: 67046
Product ID: 67046-703_7d7677eb-168d-cec7-e053-2a91aa0ac9ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: ANDA075350
Marketing category: ANDA
Marketing start: 2018-04-03
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 400 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	67046-703	67046-703-30	I	Inactivated by FDA		2026-08-11

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 · 18 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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
A075350-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12
A075350-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12
A075350-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075350-001	AB
A075350-002	AB
A075350-003	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	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2003-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2003-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075350-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2003-09-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A075350-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075350-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075350-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075350-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075350-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075350-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075350-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075350-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075350-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075350-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075350-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075350-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075350-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075350-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075350-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075350-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075350-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075350-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075350-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075350-001	AB	1	`8072bd15b7f6…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67046-703-30	2022-01-28	C162847	48780-1	d6a99b39-69f6-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-703-30	Gabapentin	30 in 1 BLISTER PACK	CAPSULE	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-703	GABAPENTIN CAPSULE [CONTRACT PHARMACY SERVICES-PA]	2	Legacy NDC, 1 package rows	20181221_74f888ce-5f84-cad0-e053-2991aa0a2d79.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	Teva Pharmaceuticals, Inc.	c7f21eaa-68ee-420c-9c98-e997cc73a297	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	b4c7388a-19d9-4e3a-83c9-4943fb855be4	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Actavis Pharma, Inc.	5969871e-6c71-4c37-9d63-370718ccc80c	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afc80b8b-da39-6fb9-e053-2a95a90a2d8e	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	77754734-4125-42b1-97c8-458bcab2bcf1	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Proficient Rx LP	c7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	e89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc8	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Proficient Rx LP	f651a143-3f88-49c9-b5c4-c9af55aea76a	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	37d4d465-19a5-46db-80dc-0b7334b3343a	2018-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	86b30e64-fe56-42b3-a0f8-d9ef5d4b8c49	2016-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075350 application number: ANDA075350

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
310432	gabapentin 400 MG Oral Capsule	PSN	74f888ce-5f84-cad0-e053-2991aa0a2d79	2
310432	gabapentin 400 MG Oral Capsule	SCD	74f888ce-5f84-cad0-e053-2991aa0a2d79	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67046-703-30	67046070330	30 CAPSULE in 1 BLISTER PACK (67046-703-30)	30 capsule	2018-04-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2018-12-20	HUMAN PRESCRIPTION DRUG LABEL	2