Felbamate

Product NDC: 51672-4172
11-digit product format: 516724172
Labeler code: 51672
Product ID: 51672-4172_ff558824-b008-4b94-8aa5-d7818bc27a4f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Felbamate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA206314
Marketing category: ANDA
Marketing start: 2017-06-16
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
A206314-001	FELBAMATE	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB		2017-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206314-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206314-001	FELBAMATE	600MG/5ML	SUSPENSION / ORAL	AB	2017-06-16	`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	A206314-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206314-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206314-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206314-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206314-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206314-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206314-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206314-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206314-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206314-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206314-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206314-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206314-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206314-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206314-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206314-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206314-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206314-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206314-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206314-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206314-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206314-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206314-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206314-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206314-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206314-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206314-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206314-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206314-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206314-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206314-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206314-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206314-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206314-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206314-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206314-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206314-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206314-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206314-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206314-001	AB	1	`cb3db0bc1861…`

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/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
0afffb17-e6ac-4bea-a90e-7ef3c8150290	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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51672-4172-1	Felbamate	237 mL in 1 BOTTLE	SUSPENSION	237		3
51672-4172-9	Felbamate	473 mL in 1 BOTTLE	SUSPENSION	473		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4172-1	ML - Milliliter	51672-4172	b9e234bf-bcb9-4c4b-a0e0-f5f48955ad08	1	2017-07-07
51672-4172-9	ML - Milliliter	51672-4172	2c09f0b8-bb48-4a6d-8f69-7eebafb066ed	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4172	FELBAMATE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	3	Current NDC, Legacy NDC, 2 package rows	20170623_0afffb17-e6ac-4bea-a90e-7ef3c8150290.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	Sun Pharmaceutical Industries, Inc.	0afffb17-e6ac-4bea-a90e-7ef3c8150290	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206314 application number: ANDA206314 ndc (product): 51672-4172
Felbamate	FELBAMATE	NORTHSTAR RX LLC	556de35d-3b98-48d3-a670-50e9d93437a4	2018-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206314 application number: ANDA206314

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	0afffb17-e6ac-4bea-a90e-7ef3c8150290	3
310285	felbamate 120 MG/ML Oral Suspension	SCD	0afffb17-e6ac-4bea-a90e-7ef3c8150290	3
310285	felbamate 600 MG per 5 ML Oral Suspension	SY	0afffb17-e6ac-4bea-a90e-7ef3c8150290	3
310285	FELT 120 MG/ML Oral Suspension	SY	0afffb17-e6ac-4bea-a90e-7ef3c8150290	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4172-1	51672417201	237 mL in 1 BOTTLE (51672-4172-1)	237 ml	2017-06-16	0000-00-00	No	No	Current
51672-4172-9	51672417209	473 mL in 1 BOTTLE (51672-4172-9)	473 ml	2017-06-16	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	Sun Pharmaceutical Industries, Inc. \| Taro Pharmaceutical Industries, Ltd.	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	4