Brivaracetam

Product NDC: 84386-068
Requested package NDC: 84386-068-60
11-digit product format: 843860068
Labeler code: 84386
Product ID: 84386-068_59817617-956e-4685-81d4-7abe42f4de86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brivaracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA214848
Marketing category: ANDA
Marketing start: 2026-07-13
Substance: BRIVARACETAM
Active strength: 10 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 43.

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
A214848-001	BRIVARACETAM	BRIVARACETAM	50MG	TABLET / ORAL	AB	2023-01-06
A214848-002	BRIVARACETAM	BRIVARACETAM	100MG	TABLET / ORAL	AB	2023-01-06
A214848-003	BRIVARACETAM	BRIVARACETAM	10MG	TABLET / ORAL	AB	2026-07-13
A214848-004	BRIVARACETAM	BRIVARACETAM	25MG	TABLET / ORAL	AB	2026-07-13
A214848-005	BRIVARACETAM	BRIVARACETAM	75MG	TABLET / ORAL	AB	2026-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214848-001	AB
A214848-002	AB
A214848-003	AB
A214848-004	AB
A214848-005	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 2 · 58 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
2026-09-14 22:38:34	2026-08	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL	AB	2023-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL	AB	2023-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-003	BRIVARACETAM	10MG	TABLET / ORAL	AB	2026-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-004	BRIVARACETAM	25MG	TABLET / ORAL	AB	2026-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-005	BRIVARACETAM	75MG	TABLET / ORAL	AB	2026-07-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL	AB	2023-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL	AB	2023-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-003	BRIVARACETAM	10MG	TABLET / ORAL	AB	2026-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-004	BRIVARACETAM	25MG	TABLET / ORAL	AB	2026-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-005	BRIVARACETAM	75MG	TABLET / ORAL	AB	2026-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL	AB	2023-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL	AB	2023-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214848-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214848-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214848-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214848-002	AB	1	`011fe1cb6892…`
2023-01-26 05:58 UTC	2023-01	A214848-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214848-002	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214848-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214848-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BRIVARACETAM	10 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1739761	Internal RxNorm lookup
1739772	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
59817617-956e-4685-81d4-7abe42f4de86	Available on FDA.report

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	Aurobindo Pharma Limited	59817617-956e-4685-81d4-7abe42f4de86	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214848 application number: ANDA214848 ndc (package): 84386-068-60 ndc (product): 84386-068 ndc11 (package): 84386006860
Brivaracetam	BRIVARACETAM	Aurobindo Pharma Limited	41e218af-048b-4e24-91d2-0b9b262d480c	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214848 application number: ANDA214848

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
84386-068-60	84386006860	60 TABLET, FILM COATED in 1 BOTTLE (84386-068-60)	2026-07-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Brivaracetam	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2026-07-14	Human Prescription Drug Label	1