Felbatol

Product NDC: 0037-0442
Requested package NDC: 0037-0442-67
11-digit product format: 000370442
Labeler code: 0037
Product ID: 0037-0442_1814c148-d0bf-405a-9e20-f3d1aa8c1d9e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: felbamate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Meda Pharmaceuticals Inc.
Application: NDA020189
Marketing category: NDA
Marketing start: 1993-07-29
Marketing end: 0000-00-00
Substance: FELBAMATE
Active strength: 600 mg/5mL
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	0037-0442	0037-0442-67	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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0037-0442	0037-0442-67	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020189-001	FELBATOL	FELBAMATE	400MG	TABLET / ORAL	AB	RLD	1993-07-29
N020189-002	FELBATOL	FELBAMATE	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29
N020189-003	FELBATOL	FELBAMATE	600MG/5ML	SUSPENSION / ORAL		RLD	1993-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020189-001	AB
N020189-002	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL		RLD	1993-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1993-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1993-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1993-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1993-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1993-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1993-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1993-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1993-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1993-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1993-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1993-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020189-002	FELBATOL	600MG	TABLET / ORAL	AB	RLD, RS	1993-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020189-003	FELBATOL	600MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	1993-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020189-001	FELBATOL	400MG	TABLET / ORAL	AB	RLD	1993-07-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 121 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	N020189-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020189-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020189-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020189-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020189-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020189-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020189-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020189-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020189-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020189-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020189-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020189-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020189-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020189-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020189-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020189-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020189-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020189-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020189-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020189-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020189-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020189-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020189-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020189-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020189-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020189-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020189-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020189-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020189-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020189-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020189-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020189-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020189-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020189-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020189-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020189-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020189-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020189-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020189-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020189-002	AB	1	`8072bd15b7f6…`

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
0037-0442-17	Felbatol	946 mL in 1 BOTTLE, PLASTIC	SUSPENSION	946		16
0037-0442-67	Felbatol	237 mL in 1 BOTTLE, PLASTIC	SUSPENSION	237		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0037-0442-17	ML - Milliliter	0037-0442	a4a8e98f-cc35-445b-97ea-56ff0c3216a6	1	2012-07-24
0037-0442-67	ML - Milliliter	0037-0442	28f29b38-110b-4b64-b4ae-e56ca2c94de0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
FELBAMATE	ACTIVE INGREDIENT	X72RBB02N8	FELBATOL (FELBAMATE) TABLET FELBATOL (FELBAMATE) SUSPENSION [MEDA PHARMACEUTICALS INC.]	5
FELBAMATE	ACTIVE MOIETY	X72RBB02N8	FELBATOL (FELBAMATE) TABLET FELBATOL (FELBAMATE) SUSPENSION [MEDA PHARMACEUTICALS INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0037-0442	FELBATOL (FELBAMATE) TABLET FELBATOL (FELBAMATE) SUSPENSION [MEDA PHARMACEUTICALS INC.]	13	Legacy NDC, 2 package rows	20241013_2f522701-397a-11de-8a39-0800200c9a66.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felbatol	FELBAMATE	Viatris Specialty LLC	2f522701-397a-11de-8a39-0800200c9a66	2025-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020189 application number: NDA020189 ndc (package): 0037-0442-67 ndc (product): 0037-0442 ndc11 (package): 00037044267

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	2f522701-397a-11de-8a39-0800200c9a66	16
310285	felbamate 600 MG in 5 mL Oral Suspension	PSN	2f522701-397a-11de-8a39-0800200c9a66	16
198359	felbamate 600 MG Oral Tablet	PSN	2f522701-397a-11de-8a39-0800200c9a66	16
209026	Felbatol 400 MG Oral Tablet	PSN	2f522701-397a-11de-8a39-0800200c9a66	16
209028	Felbatol 600 MG in 5 mL Oral Suspension	PSN	2f522701-397a-11de-8a39-0800200c9a66	16
209027	Felbatol 600 MG Oral Tablet	PSN	2f522701-397a-11de-8a39-0800200c9a66	16
209028	felbamate 120 MG/ML Oral Suspension [Felbatol]	SBD	2f522701-397a-11de-8a39-0800200c9a66	16
209026	felbamate 400 MG Oral Tablet [Felbatol]	SBD	2f522701-397a-11de-8a39-0800200c9a66	16
209027	felbamate 600 MG Oral Tablet [Felbatol]	SBD	2f522701-397a-11de-8a39-0800200c9a66	16
310285	felbamate 120 MG/ML Oral Suspension	SCD	2f522701-397a-11de-8a39-0800200c9a66	16
198358	felbamate 400 MG Oral Tablet	SCD	2f522701-397a-11de-8a39-0800200c9a66	16
198359	felbamate 600 MG Oral Tablet	SCD	2f522701-397a-11de-8a39-0800200c9a66	16
310285	felbamate 600 MG per 5 ML Oral Suspension	SY	2f522701-397a-11de-8a39-0800200c9a66	16
209028	Felbatol 120 MG/ML Oral Suspension	SY	2f522701-397a-11de-8a39-0800200c9a66	16
209026	Felbatol 400 MG Oral Tablet	SY	2f522701-397a-11de-8a39-0800200c9a66	16
209027	Felbatol 600 MG Oral Tablet	SY	2f522701-397a-11de-8a39-0800200c9a66	16
209028	Felbatol 600 MG per 5 ML Oral Suspension	SY	2f522701-397a-11de-8a39-0800200c9a66	16
310285	FELT 120 MG/ML Oral Suspension	SY	2f522701-397a-11de-8a39-0800200c9a66	16
209028	FELT 120 MG/ML Oral Suspension [Felbatol]	SY	2f522701-397a-11de-8a39-0800200c9a66	16
198358	FELT 400 MG Oral Tablet	SY	2f522701-397a-11de-8a39-0800200c9a66	16
209026	FELT 400 MG Oral Tablet [Felbatol]	SY	2f522701-397a-11de-8a39-0800200c9a66	16
198359	FELT 600 MG Oral Tablet	SY	2f522701-397a-11de-8a39-0800200c9a66	16
209027	FELT 600 MG Oral Tablet [Felbatol]	SY	2f522701-397a-11de-8a39-0800200c9a66	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0037-0442-67	00037044267	237 mL in 1 BOTTLE, PLASTIC (0037-0442-67)	237 ml	1993-07-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Felbatol - Viatris Specialty LLC	Viatris Specialty LLC	2025-08-15	HUMAN PRESCRIPTION DRUG LABEL	16