brivaracetam

Product NDC: 73473-908
11-digit product format: 734730908
Labeler code: 73473
Product ID: 73473-908_49f726ff-d8e7-7781-e063-6294a90a36f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: brivaracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Solaris�Pharma�Corporation
Application: ANDA214748
Marketing category: ANDA
Marketing start: 2026-02-04
Substance: BRIVARACETAM
Active strength: 100 mg/1
Pharmacologic classes: Epoxide Hydrolase Inhibitors [MoA]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214748-001	BRIVARACETAM	BRIVARACETAM	10MG	TABLET / ORAL	AB	2022-06-09
A214748-002	BRIVARACETAM	BRIVARACETAM	25MG	TABLET / ORAL	AB	2022-06-09
A214748-003	BRIVARACETAM	BRIVARACETAM	50MG	TABLET / ORAL	AB	2022-06-09
A214748-004	BRIVARACETAM	BRIVARACETAM	75MG	TABLET / ORAL	AB	2022-06-09
A214748-005	BRIVARACETAM	BRIVARACETAM	100MG	TABLET / ORAL	AB	2022-06-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A214748-001	AB
A214748-002	AB
A214748-003	AB
A214748-004	AB
A214748-005	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 · 140 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	A214748-001	BRIVARACETAM	10MG	TABLET / ORAL	AB	2022-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214748-002	BRIVARACETAM	25MG	TABLET / ORAL	AB	2022-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214748-003	BRIVARACETAM	50MG	TABLET / ORAL	AB	2022-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214748-004	BRIVARACETAM	75MG	TABLET / ORAL	AB	2022-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214748-005	BRIVARACETAM	100MG	TABLET / ORAL	AB	2022-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214748-001	BRIVARACETAM	10MG	TABLET / ORAL		2022-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214748-002	BRIVARACETAM	25MG	TABLET / ORAL		2022-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214748-003	BRIVARACETAM	50MG	TABLET / ORAL		2022-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214748-004	BRIVARACETAM	75MG	TABLET / ORAL		2022-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214748-005	BRIVARACETAM	100MG	TABLET / ORAL		2022-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214748-001	BRIVARACETAM	10MG	TABLET / ORAL		2022-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214748-002	BRIVARACETAM	25MG	TABLET / ORAL		2022-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214748-003	BRIVARACETAM	50MG	TABLET / ORAL		2022-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214748-004	BRIVARACETAM	75MG	TABLET / ORAL		2022-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214748-005	BRIVARACETAM	100MG	TABLET / ORAL		2022-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214748-001	BRIVARACETAM	10MG	TABLET / ORAL		2022-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214748-002	BRIVARACETAM	25MG	TABLET / ORAL		2022-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214748-003	BRIVARACETAM	50MG	TABLET / ORAL		2022-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214748-004	BRIVARACETAM	75MG	TABLET / ORAL		2022-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214748-005	BRIVARACETAM	100MG	TABLET / ORAL		2022-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214748-001	BRIVARACETAM	10MG	TABLET / ORAL		2022-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214748-002	BRIVARACETAM	25MG	TABLET / ORAL		2022-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214748-003	BRIVARACETAM	50MG	TABLET / ORAL		2022-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214748-004	BRIVARACETAM	75MG	TABLET / ORAL		2022-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214748-005	BRIVARACETAM	100MG	TABLET / ORAL		2022-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214748-001	BRIVARACETAM	10MG	TABLET / ORAL		2022-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214748-002	BRIVARACETAM	25MG	TABLET / ORAL		2022-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214748-003	BRIVARACETAM	50MG	TABLET / ORAL		2022-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214748-004	BRIVARACETAM	75MG	TABLET / ORAL		2022-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214748-005	BRIVARACETAM	100MG	TABLET / ORAL		2022-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214748-001	BRIVARACETAM	10MG	TABLET / ORAL		2022-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214748-002	BRIVARACETAM	25MG	TABLET / ORAL		2022-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214748-003	BRIVARACETAM	50MG	TABLET / ORAL		2022-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214748-004	BRIVARACETAM	75MG	TABLET / ORAL		2022-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214748-005	BRIVARACETAM	100MG	TABLET / ORAL		2022-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214748-001	BRIVARACETAM	10MG	TABLET / ORAL		2022-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214748-002	BRIVARACETAM	25MG	TABLET / ORAL		2022-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214748-003	BRIVARACETAM	50MG	TABLET / ORAL		2022-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214748-004	BRIVARACETAM	75MG	TABLET / ORAL		2022-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214748-005	BRIVARACETAM	100MG	TABLET / ORAL		2022-06-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214748-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214748-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214748-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214748-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214748-005	AB	1	`011fe1cb6892…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214748-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214748-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214748-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214748-004	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214748-005	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214748-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214748-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214748-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214748-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214748-005	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: brivaracetam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BRIVARACETAM	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U863JGG2IA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1739761	Internal RxNorm lookup
1739768	Internal RxNorm lookup
1739772	Internal RxNorm lookup
1739776	Internal RxNorm lookup
1739780	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
49f726ec-e51b-7516-e063-6294a90ae684	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
1447c696-6954-40c0-b275-6f6c780ca8b7	Product name	1	20160323
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73473-908-60	brivaracetam	60 in 1 BOTTLE	TABLET, FILM COATED	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73473-908-60	EA - Each	73473-908	bd8a75e9-e7dc-4ea5-ab78-746cfe695886	1	2026-05-22

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
brivaracetam	BRIVARACETAM	SolarisPharmaCorporation	49f726ec-e51b-7516-e063-6294a90ae684	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214748 application number: ANDA214748 ndc (product): 73473-908

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U863JGG2IA	BRIVARACETAM	357336-20-0	BRIVARACETAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1739761	brivaracetam 10 MG Oral Tablet	PSN	49f726ec-e51b-7516-e063-6294a90ae684	2
1739768	brivaracetam 100 MG Oral Tablet	PSN	49f726ec-e51b-7516-e063-6294a90ae684	2
1739772	brivaracetam 25 MG Oral Tablet	PSN	49f726ec-e51b-7516-e063-6294a90ae684	2
1739776	brivaracetam 50 MG Oral Tablet	PSN	49f726ec-e51b-7516-e063-6294a90ae684	2
1739780	brivaracetam 75 MG Oral Tablet	PSN	49f726ec-e51b-7516-e063-6294a90ae684	2
1739761	brivaracetam 10 MG Oral Tablet	SCD	49f726ec-e51b-7516-e063-6294a90ae684	2
1739768	brivaracetam 100 MG Oral Tablet	SCD	49f726ec-e51b-7516-e063-6294a90ae684	2
1739772	brivaracetam 25 MG Oral Tablet	SCD	49f726ec-e51b-7516-e063-6294a90ae684	2
1739776	brivaracetam 50 MG Oral Tablet	SCD	49f726ec-e51b-7516-e063-6294a90ae684	2
1739780	brivaracetam 75 MG Oral Tablet	SCD	49f726ec-e51b-7516-e063-6294a90ae684	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
73473-908-60	73473090860	60 TABLET, FILM COATED in 1 BOTTLE (73473-908-60)	2026-02-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
brivaracetam	Solaris Pharma Corporation \| Sunshine Lake Pharma Co., Ltd.	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	2