GABAPENTIN

Product NDC: 43353-190
Requested package NDC: 43353-190-92
11-digit product format: 433530190
Labeler code: 43353
Product ID: 43353-190_0fff2a2a-4229-4cef-9ea1-d0c63e9c2821
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gabapentin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA202764
Marketing category: ANDA
Marketing start: 2012-11-02
Marketing end: 0000-00-00
Substance: GABAPENTIN
Active strength: 800 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	43353-190	43353-190-92	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 · 15 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…`

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
A202764-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL			2012-10-16
A202764-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL			2012-10-16

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	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202764-001	GABAPENTIN	600MG	TABLET / ORAL		2012-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202764-002	GABAPENTIN	800MG	TABLET / ORAL		2012-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202764-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2012-10-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202764-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2012-10-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202764-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202764-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202764-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202764-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202764-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202764-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202764-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202764-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202764-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202764-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202764-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202764-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202764-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202764-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202764-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202764-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202764-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202764-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202764-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202764-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202764-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202764-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202764-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202764-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202764-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202764-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202764-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202764-002	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202764-001	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202764-002	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202764-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202764-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202764-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202764-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202764-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202764-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202764-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202764-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202764-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202764-002	AB	1	`3f0d92c62455…`

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
fa3f0129-3502-889f-f424-3a37727959e7	Product name	9	20181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2b	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43353-190-45	Gabapentin Tablets, USP Rx Only
43353-190-53	Gabapentin Tablets, USP Rx Only
43353-190-60	Gabapentin Tablets, USP Rx Only
43353-190-70	Gabapentin Tablets, USP Rx Only
43353-190-92	Gabapentin Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-190-45	GABAPENTIN	45 in 1 BOTTLE	TABLET, FILM COATED	45	6
43353-190-53	GABAPENTIN	60 in 1 BOTTLE	TABLET, FILM COATED	60	6
43353-190-60	GABAPENTIN	90 in 1 BOTTLE	TABLET, FILM COATED	90	6
43353-190-70	GABAPENTIN	120 in 1 BOTTLE	TABLET, FILM COATED	120	6
43353-190-92	GABAPENTIN	270 in 1 BOTTLE	TABLET, FILM COATED	270	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-190-45	EA - Each	43353-190	5c74c113-a240-4871-ad68-4a080c791ea5	1	2020-07-13
43353-190-53	EA - Each	43353-190	b8d05fd0-ef14-48a9-bdb5-123268420b7b	1	2020-07-13
43353-190-60	EA - Each	43353-190	706d4885-48cb-4df2-8264-bf4467d8872f	1	2021-03-02
43353-190-70	EA - Each	43353-190	43e39475-e259-4163-90cd-d51b6fa94926	1	2017-10-13
43353-190-92	EA - Each	43353-190	a56bd881-b1a6-47a4-99d3-8707b503b7f3	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-190	GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	6	Legacy NDC, 5 package rows	20210124_11da2692-fb0a-4519-b8a4-323c7a6eeb4d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Exelan Pharmaceuticals Inc.	323dad14-ded9-4432-a265-c957e46cc6db	2023-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202764 application number: ANDA202764
Gabapentin	GABAPENTIN	Cipla USA Inc.	7c3ac86f-b8f7-42bf-942a-db854d946e54	2023-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202764 application number: ANDA202764
Gabapentin	GABAPENTIN	Proficient Rx LP	f6baeb5c-ca9c-4730-aeb8-8f8732e8ca3a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202764 application number: ANDA202764

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	11da2692-fb0a-4519-b8a4-323c7a6eeb4d	6
310434	gabapentin 800 MG Oral Tablet	SCD	11da2692-fb0a-4519-b8a4-323c7a6eeb4d	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-190-92	43353019092	270 TABLET, FILM COATED in 1 BOTTLE (43353-190-92)	2016-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gabapentin Tablets, USP Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2021-01-22	Human Prescription Drug Label	6