Felbamate Tablets, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-08-16
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 21:11:00

Label at a glance#

ProductFelbamate

Active ingredientFELBAMATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1077-1

Felbamate tablets USP, 400 mg

100 Tablets

Rx only

NDC 70771-1078-1

Felbamate tablets USP, 600 mg

100 Tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198358	felbamate 400 MG Oral Tablet	PSN	6
198359	felbamate 600 MG Oral Tablet	PSN	6
198358	felbamate 400 MG Oral Tablet	SCD	6
198359	felbamate 600 MG Oral Tablet	SCD	6
198358	FELT 400 MG Oral Tablet	SY	6
198359	FELT 600 MG Oral Tablet	SY	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FELBAMATE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

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
70771-1077-1	Felbamate	100 in 1 BOTTLE	TABLET	100	6
70771-1077-3	Felbamate	30 in 1 BOTTLE	TABLET	30	6
70771-1077-4	Felbamate	10 in 1 BLISTER PACK	TABLET	10	6
70771-1077-4	Felbamate	10 in 1 CARTON	TABLET	10	6
70771-1077-5	Felbamate	500 in 1 BOTTLE	TABLET	500	6
70771-1077-9	Felbamate	90 in 1 BOTTLE	TABLET	90	6
70771-1078-1	Felbamate	100 in 1 BOTTLE	TABLET	100	6
70771-1078-3	Felbamate	30 in 1 BOTTLE	TABLET	30	6
70771-1078-4	Felbamate	10 in 1 BLISTER PACK	TABLET	10	6
70771-1078-4	Felbamate	10 in 1 CARTON	TABLET	10	6
70771-1078-5	Felbamate	500 in 1 BOTTLE	TABLET	500	6
70771-1078-8	Felbamate	180 in 1 BOTTLE	TABLET	180	6
70771-1078-9	Felbamate	90 in 1 BOTTLE	TABLET	90	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1077	FELBAMATE TABLET [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 6 package rows	20240821_efa55cb2-b625-4392-9ddb-0a8ad8ee58c4.zip
70771-1078	FELBAMATE TABLET [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 7 package rows	20240821_efa55cb2-b625-4392-9ddb-0a8ad8ee58c4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Felbamate
ALUMINUM OXIDE
CELLULOSE, MICROCRYSTALLINE
FD&C RED NO. 40
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
D&C YELLOW NO. 10

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1077	70771-1077-3, 70771-1077-9, 70771-1077-1, 70771-1077-5, 70771-1077-4
70771-1078	70771-1078-3, 70771-1078-9, 70771-1078-1, 70771-1078-5, 70771-1078-4, 70771-1078-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FELBAMATE	X72RBB02N8	ACTIB
ALUMINUM OXIDE	LMI26O6933	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE K30	U725QWY32X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
FELBAMATE	X72RBB02N8	ACTIB
ALUMINUM OXIDE	LMI26O6933	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE K30	U725QWY32X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208970-001	FELBAMATE	400MG	TABLET / ORAL	AB	2017-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208970-002	FELBAMATE	600MG	TABLET / ORAL	AB	2017-05-30	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208970-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208970-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208970-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208970-002	AB	1	`caaa826d4ba7…`
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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felbamate	FELBAMATE	Zydus Lifesciences Limited	efa55cb2-b625-4392-9ddb-0a8ad8ee58c4	2024-08-16		Exact identifier ndc (package): 70771-1077-9 ndc (package): 70771-1077-4 ndc (package): 70771-1078-1 ndc (package): 70771-1077-5 ndc (package): 70771-1078-9 ndc (package): 70771-1077-1 ndc (package): 70771-1078-3 ndc (package): 70771-1078-8 ndc (package): 70771-1078-4 ndc (package): 70771-1077-3 ndc (package): 70771-1078-5 ndc (product): 70771-1078 ndc (product): 70771-1077 ndc11 (package): 70771107703 ndc11 (package): 70771107701 ndc11 (package): 70771107709 ndc11 (package): 70771107803 ndc11 (package): 70771107805 ndc11 (package): 70771107804 ndc11 (package): 70771107808 ndc11 (package): 70771107705 ndc11 (package): 70771107809 ndc11 (package): 70771107801 ndc11 (package): 70771107704 spl id: 785f1747-e29d-432a-82e7-fcaeea202327 spl set id: efa55cb2-b625-4392-9ddb-0a8ad8ee58c4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.