Felbamate

Product NDC: 62559-730
11-digit product format: 625590730
Labeler code: 62559
Product ID: 62559-730_76100661-b064-4f19-b9ba-8ba4adcf042f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Felbamate
Dosage form: TABLET
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA202284
Marketing category: ANDA
Marketing start: 2018-09-04
Substance: FELBAMATE
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Felbamate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FELBAMATE	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X72RBB02N8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198358	Internal RxNorm lookup
198359	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
17850520-f823-4d05-8f9b-5eadfa68bae2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b0edd10c-1754-6637-302d-00e8fb86191c	Product name	5	20190828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62559-730-01	Felbamate	100 in 1 BOTTLE	TABLET	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-730-01	EA - Each	62559-730	1f967b62-e675-4ffc-b41b-e7c07ba5b8ae	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62559-730	FELBAMATE TABLET [ANI PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250206_17850520-f823-4d05-8f9b-5eadfa68bae2.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 · 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 ndc (product): 62559-730
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X72RBB02N8	FELBAMATE	25451-15-4	FELBAMATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198358	felbamate 400 MG Oral Tablet	PSN	6afd77f2-4525-42f4-a4b1-94159c401dd2	106
198358	felbamate 400 MG Oral Tablet	SCD	6afd77f2-4525-42f4-a4b1-94159c401dd2	106
198358	FELT 400 MG Oral Tablet	SY	6afd77f2-4525-42f4-a4b1-94159c401dd2	106
198358	felbamate 400 MG Oral Tablet	PSN	d6eaf094-09e2-480c-bea9-7a2768aad884	102
198358	felbamate 400 MG Oral Tablet	SCD	d6eaf094-09e2-480c-bea9-7a2768aad884	102
198358	FELT 400 MG Oral Tablet	SY	d6eaf094-09e2-480c-bea9-7a2768aad884	102
198358	felbamate 400 MG Oral Tablet	PSN	17850520-f823-4d05-8f9b-5eadfa68bae2	5
198359	felbamate 600 MG Oral Tablet	PSN	17850520-f823-4d05-8f9b-5eadfa68bae2	5
198358	felbamate 400 MG Oral Tablet	SCD	17850520-f823-4d05-8f9b-5eadfa68bae2	5
198359	felbamate 600 MG Oral Tablet	SCD	17850520-f823-4d05-8f9b-5eadfa68bae2	5
198358	FELT 400 MG Oral Tablet	SY	17850520-f823-4d05-8f9b-5eadfa68bae2	5
198359	FELT 600 MG Oral Tablet	SY	17850520-f823-4d05-8f9b-5eadfa68bae2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62559-730-01	62559073001	100 TABLET in 1 BOTTLE (62559-730-01)	100 tablet	2018-09-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Felbamate - Bryant Ranch Prepack	Bryant Ranch Prepack	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	106
Felbamate - Bryant Ranch Prepack	Bryant Ranch Prepack	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	102
Felbamate - ANI Pharmaceuticals, Inc.	ANI Pharmaceuticals, Inc.	2025-11-07	HUMAN PRESCRIPTION DRUG LABEL	5