brivaracetam

Product NDC: 70771-1756
11-digit product format: 707711756
Labeler code: 70771
Product ID: 70771-1756_43d4b6c1-4756-4199-90f9-d91d9c81c861
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: brivaracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA214501
Marketing category: ANDA
Marketing start: 2026-02-21
Substance: BRIVARACETAM
Active strength: 50 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
A214501-001	BRIVARACETAM	BRIVARACETAM	10MG	TABLET / ORAL	AB	2022-10-03
A214501-002	BRIVARACETAM	BRIVARACETAM	25MG	TABLET / ORAL	AB	2022-10-03
A214501-003	BRIVARACETAM	BRIVARACETAM	50MG	TABLET / ORAL	AB	2022-10-03
A214501-004	BRIVARACETAM	BRIVARACETAM	75MG	TABLET / ORAL	AB	2022-10-03
A214501-005	BRIVARACETAM	BRIVARACETAM	100MG	TABLET / ORAL	AB	2022-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214501-001	AB
A214501-002	AB
A214501-003	AB
A214501-004	AB
A214501-005	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 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214501-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214501-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214501-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214501-004	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214501-005	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214501-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214501-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214501-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214501-004	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214501-005	AB	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214501-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214501-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214501-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214501-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214501-005	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	50 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
67c4db20-ba4d-4640-9e9c-6949b85429e3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1447c696-6954-40c0-b275-6f6c780ca8b7	Product name	1	20160323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1756-4	brivaracetam	100 in 1 CARTON	TABLET, FILM COATED	100	4
70771-1756-6	brivaracetam	60 in 1 BOTTLE	TABLET, FILM COATED	60	4
70771-1756-7	brivaracetam	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	4
70771-1756-8	brivaracetam	180 in 1 BOTTLE	TABLET, FILM COATED	180	4

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
brivaracetam	BRIVARACETAM	Zydus Lifesciences Limited	67c4db20-ba4d-4640-9e9c-6949b85429e3	2026-01-27		Exact identifier application applno (ANDA): 214501 application number: ANDA214501 ndc (product): 70771-1756
brivaracetam	BRIVARACETAM	Zydus Pharmaceuticals USA Inc.	d54ca946-2ddf-4a67-87c9-20a814bfd2dc	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214501 application number: ANDA214501

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	67c4db20-ba4d-4640-9e9c-6949b85429e3	4
1739768	brivaracetam 100 MG Oral Tablet	PSN	67c4db20-ba4d-4640-9e9c-6949b85429e3	4
1739772	brivaracetam 25 MG Oral Tablet	PSN	67c4db20-ba4d-4640-9e9c-6949b85429e3	4
1739776	brivaracetam 50 MG Oral Tablet	PSN	67c4db20-ba4d-4640-9e9c-6949b85429e3	4
1739780	brivaracetam 75 MG Oral Tablet	PSN	67c4db20-ba4d-4640-9e9c-6949b85429e3	4
1739761	brivaracetam 10 MG Oral Tablet	SCD	67c4db20-ba4d-4640-9e9c-6949b85429e3	4
1739768	brivaracetam 100 MG Oral Tablet	SCD	67c4db20-ba4d-4640-9e9c-6949b85429e3	4
1739772	brivaracetam 25 MG Oral Tablet	SCD	67c4db20-ba4d-4640-9e9c-6949b85429e3	4
1739776	brivaracetam 50 MG Oral Tablet	SCD	67c4db20-ba4d-4640-9e9c-6949b85429e3	4
1739780	brivaracetam 75 MG Oral Tablet	SCD	67c4db20-ba4d-4640-9e9c-6949b85429e3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70771-1756-4	70771175604	100 BLISTER PACK in 1 CARTON (70771-1756-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK (70771-1756-7)	100 blister pack	2026-02-21	No	No	Current
70771-1756-6	70771175606	60 TABLET, FILM COATED in 1 BOTTLE (70771-1756-6)		2026-02-21	No	No	Current
70771-1756-7	70771175607	1 in 1 BLISTER PACK					Historical
70771-1756-8	70771175608	180 TABLET, FILM COATED in 1 BOTTLE (70771-1756-8)		2026-02-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BRIVARACETAM tablets, for oral use, CV	Zydus Lifesciences Limited	2026-01-27	HUMAN PRESCRIPTION DRUG LABEL	4