Felbamate

Product NDC: 72578-057
11-digit product format: 725780057
Labeler code: 72578
Product ID: 72578-057_e719dd84-3938-4531-871c-4433fec8f4a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Felbamate
Dosage form: TABLET
Route: ORAL
Labeler: Viona Pharmaceuticals Inc
Application: ANDA208970
Marketing category: ANDA
Marketing start: 2020-03-03
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: 2027-12-31
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
A208970-001	FELBAMATE	FELBAMATE	400MG	TABLET / ORAL	AB		2017-05-30
A208970-002	FELBAMATE	FELBAMATE	600MG	TABLET / ORAL	AB		2017-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208970-001	AB
A208970-002	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	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`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	A208970-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208970-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208970-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208970-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208970-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208970-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208970-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208970-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208970-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208970-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208970-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208970-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208970-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208970-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208970-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208970-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208970-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208970-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208970-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208970-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208970-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208970-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208970-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208970-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208970-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208970-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208970-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208970-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208970-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208970-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208970-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208970-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208970-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208970-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208970-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208970-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208970-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208970-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208970-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208970-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Felbamate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FELBAMATE	600 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
96f4357c-720c-4651-b638-7b1181531dc5	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	SPL version
72578-057-01	Felbamate	100 in 1 BOTTLE	TABLET	100	3
72578-057-05	Felbamate	500 in 1 BOTTLE	TABLET	500	3
72578-057-06	Felbamate	30 in 1 BOTTLE	TABLET	30	3
72578-057-16	Felbamate	90 in 1 BOTTLE	TABLET	90	3
72578-057-28	Felbamate	180 in 1 BOTTLE	TABLET	180	3
72578-057-30	Felbamate	10 in 1 BLISTER PACK	TABLET	10	3
72578-057-77	Felbamate	10 in 1 CARTON	TABLET	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72578-057-01	EA - Each	72578-057	213710cd-f7b1-47fa-ac31-2e27ac77b1ed	1	2021-03-02
72578-057-16	EA - Each	72578-057	bbb59c29-22bd-4e8a-8028-371fec34282d	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72578-057	FELBAMATE TABLET [VIONA PHARMACEUTICALS INC]	2	Current NDC, Legacy NDC, 7 package rows	20221122_96f4357c-720c-4651-b638-7b1181531dc5.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felbamate	FELBAMATE	Viona Pharmaceuticals Inc	96f4357c-720c-4651-b638-7b1181531dc5	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208970 application number: ANDA208970 ndc (product): 72578-057
Felbamate	FELBAMATE	Zydus Lifesciences Limited	efa55cb2-b625-4392-9ddb-0a8ad8ee58c4	2024-08-16		Exact identifier application applno (ANDA): 208970 application number: ANDA208970

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	96f4357c-720c-4651-b638-7b1181531dc5	3
198359	felbamate 600 MG Oral Tablet	PSN	96f4357c-720c-4651-b638-7b1181531dc5	3
198358	felbamate 400 MG Oral Tablet	SCD	96f4357c-720c-4651-b638-7b1181531dc5	3
198359	felbamate 600 MG Oral Tablet	SCD	96f4357c-720c-4651-b638-7b1181531dc5	3
198358	FELT 400 MG Oral Tablet	SY	96f4357c-720c-4651-b638-7b1181531dc5	3
198359	FELT 600 MG Oral Tablet	SY	96f4357c-720c-4651-b638-7b1181531dc5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72578-057-01	72578005701	100 TABLET in 1 BOTTLE (72578-057-01)	100 tablet	2020-03-03	0000-00-00	No	No	Current
72578-057-05	72578005705	500 TABLET in 1 BOTTLE (72578-057-05)	500 tablet	2020-03-03	0000-00-00	No	No	Current
72578-057-06	72578005706	30 TABLET in 1 BOTTLE (72578-057-06)	30 tablet	2020-03-03	0000-00-00	No	No	Current
72578-057-16	72578005716	90 TABLET in 1 BOTTLE (72578-057-16)	90 tablet	2020-03-03	0000-00-00	No	No	Current
72578-057-28	72578005728	180 TABLET in 1 BOTTLE (72578-057-28)	180 tablet	2020-03-03	0000-00-00	No	No	Current
72578-057-30	72578005730	10 in 1 BLISTER PACK						Historical
72578-057-77	72578005777	10 BLISTER PACK in 1 CARTON (72578-057-77) / 10 TABLET in 1 BLISTER PACK (72578-057-30)	10 blister pack	2020-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Felbamate Tablets, USP	Viona Pharmaceuticals Inc \| Zydus Lifesciences Limited	2026-01-29	HUMAN PRESCRIPTION DRUG LABEL	3