Felbamate

Product NDC: 0115-1747
11-digit product format: 001151747
Labeler code: 0115
Product ID: 0115-1747_514cea72-d27c-4f6c-8232-ecee781c0036
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Felbamate
Dosage form: TABLET
Route: ORAL
Labeler: Impax Generics
Application: ANDA202284
Marketing category: ANDA
Marketing start: 2017-03-06
Marketing end: 2019-12-31
Substance: FELBAMATE
Active strength: 600 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0115-1747		D	Discontinued by firm		2026-08-11
excluded package	package	0115-1747	0115-1747-01	D	Discontinued by firm		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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-1747-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0115-1747-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0115-1747-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0115-1747-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0115-1747-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0115-1747-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0115-1747-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0115-1747-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0115-1747-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0115-1747-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0115-1747-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0115-1747-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A202284-001	FELBAMATE	FELBAMATE	400MG	TABLET / ORAL	AB		2015-11-04
A202284-002	FELBAMATE	FELBAMATE	600MG	TABLET / ORAL	AB		2015-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202284-001	AB
A202284-002	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 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	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202284-001	FELBAMATE	400MG	TABLET / ORAL	AB	2015-11-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202284-002	FELBAMATE	600MG	TABLET / ORAL	AB	2015-11-04	`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	A202284-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202284-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202284-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202284-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202284-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202284-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202284-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202284-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202284-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202284-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202284-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202284-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202284-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202284-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202284-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202284-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202284-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202284-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202284-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202284-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202284-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202284-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202284-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202284-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202284-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202284-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202284-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202284-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202284-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202284-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202284-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202284-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202284-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202284-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202284-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202284-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202284-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202284-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202284-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202284-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1747-01	EA - Each	0115-1747	94debb0f-b523-4183-aa69-96d8bd2d90e6	1	2018-05-09

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felbamate	FELBAMATE	Bryant Ranch Prepack	6afd77f2-4525-42f4-a4b1-94159c401dd2	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202284 application number: ANDA202284
Felbamate	FELBAMATE	Bryant Ranch Prepack	d6eaf094-09e2-480c-bea9-7a2768aad884	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202284 application number: ANDA202284
Felbamate	FELBAMATE	Bryant Ranch Prepack	696e3cbb-a431-4f29-acbd-1db8e9aaef93	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202284 application number: ANDA202284
Felbamate	FELBAMATE	ANI Pharmaceuticals, Inc.	17850520-f823-4d05-8f9b-5eadfa68bae2	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202284 application number: ANDA202284
Felbamate	FELBAMATE	Bryant Ranch Prepack	3170233c-0452-4150-9e4c-dfffcde7424e	2025-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202284 application number: ANDA202284