Felbamate

Product NDC: 66689-825
11-digit product format: 666890825
Labeler code: 66689
Product ID: 66689-825_c5c995bf-8fbe-415d-94f5-22c875f086c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Felbamate
Dosage form: SUSPENSION
Route: ORAL
Labeler: VistaPharm, Inc.
Application: ANDA211333
Marketing category: ANDA
Marketing start: 2019-06-24
Marketing end: 2024-01-31
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66689-825		D	Discontinued by firm	2026-08-11
excluded package	package	66689-825	66689-825-08	D	Discontinued by firm	2026-08-11
excluded package	package	66689-825	66689-825-16	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 · 36 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	66689-825-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66689-825-16	`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	66689-825-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66689-825-16	`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	66689-825-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66689-825-16	`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	66689-825-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66689-825-16	`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	66689-825-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66689-825-16	`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	66689-825-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66689-825-16	`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	66689-825-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66689-825-16	`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	66689-825-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66689-825-16	`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	66689-825-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66689-825-16	`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	66689-825-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66689-825-16	`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	66689-825-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66689-825-16	`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	66689-825-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66689-825-16	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211333-001	FELBAMATE	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	RS	2019-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211333-001	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 2 · 41 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	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	RS	2019-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211333-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2019-05-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A211333-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211333-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211333-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211333-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211333-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211333-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211333-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211333-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211333-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211333-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211333-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211333-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211333-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211333-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211333-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211333-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211333-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211333-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211333-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211333-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211333-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211333-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211333-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211333-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211333-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211333-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211333-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211333-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211333-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211333-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211333-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211333-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211333-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211333-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211333-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211333-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211333-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211333-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211333-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211333-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66689-825-08	ML - Milliliter	66689-825	cbdecdb0-e928-48cb-9547-57c5c4595125	1	2019-07-02
66689-825-16	ML - Milliliter	66689-825	f7870843-6a84-46c4-9b0f-2f3462f629ff	1	2019-12-10

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	Novitium Pharma LLC	81c8a2e1-732c-4467-84e9-53fef1655ee2	2022-09-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211333 application number: ANDA211333

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66689-825-08	66689082508	237 mL in 1 BOTTLE, PLASTIC (66689-825-08)	237 ml	2019-06-24	0000-00-00	No	No	Current
66689-825-16	66689082516	1 BOTTLE, PLASTIC in 1 CARTON (66689-825-16) > 473 mL in 1 BOTTLE, PLASTIC		2019-10-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Felbamate Oral Suspension, USP 600 mg/5 mL	VistaPharm, Inc.	2022-03-09	HUMAN PRESCRIPTION DRUG LABEL	9