Felbamate

Product NDC: 70954-051
11-digit product format: 709540051
Labeler code: 70954
Product ID: 70954-051_ca7073d4-4e4c-48b5-892a-2c33fa54062d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Felbamate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Novitium Pharma LLC
Application: ANDA211333
Marketing category: ANDA
Marketing start: 2022-07-15
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: 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 · 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FELBAMATE	600 mg/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310285	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
81c8a2e1-732c-4467-84e9-53fef1655ee2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
b0edd10c-1754-6637-302d-00e8fb86191c	Product name	5	20190828
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70954-051-10	Felbamate	237 mL in 1 BOTTLE	SUSPENSION	237		2
70954-051-20	Felbamate	473 mL in 1 BOTTLE	SUSPENSION	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70954-051-10	ML - Milliliter	70954-051	e84b886c-3b0b-4258-a80c-f82cf69e6404	1	2022-08-04
70954-051-20	ML - Milliliter	70954-051	b409bfe0-2d05-4803-99cf-f86bcb2beec7	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70954-051	FELBAMATE SUSPENSION [NOVITIUM PHARMA LLC]	2	Current NDC, Legacy NDC, 2 package rows	20221021_81c8a2e1-732c-4467-84e9-53fef1655ee2.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
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 ndc (product): 70954-051

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
310285	felbamate 600 MG in 5 mL Oral Suspension	PSN	81c8a2e1-732c-4467-84e9-53fef1655ee2	2
310285	felbamate 120 MG/ML Oral Suspension	SCD	81c8a2e1-732c-4467-84e9-53fef1655ee2	2
310285	felbamate 600 MG per 5 ML Oral Suspension	SY	81c8a2e1-732c-4467-84e9-53fef1655ee2	2
310285	FELT 120 MG/ML Oral Suspension	SY	81c8a2e1-732c-4467-84e9-53fef1655ee2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70954-051-10	70954005110	237 mL in 1 BOTTLE (70954-051-10)	237 ml	2022-07-15	0000-00-00	No	No	Current
70954-051-20	70954005120	473 mL in 1 BOTTLE (70954-051-20)	473 ml	2022-07-15	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	Novitium Pharma LLC	2022-09-13	Human Prescription Drug Label	2