brivaracetam

Product NDC
70710-1584
11-digit product format
707101584
Labeler code
70710
Product ID
70710-1584_dd7c5f3e-5cd5-4219-bf1a-7fe15b291998
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brivaracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA214501
Marketing category
ANDA
Marketing start
2026-02-21
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 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214501-001BRIVARACETAMBRIVARACETAM10MGTABLET / ORALAB2022-10-03
A214501-002BRIVARACETAMBRIVARACETAM25MGTABLET / ORALAB2022-10-03
A214501-003BRIVARACETAMBRIVARACETAM50MGTABLET / ORALAB2022-10-03
A214501-004BRIVARACETAMBRIVARACETAM75MGTABLET / ORALAB2022-10-03
A214501-005BRIVARACETAMBRIVARACETAM100MGTABLET / ORALAB2022-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214501-001AB
A214501-002AB
A214501-003AB
A214501-004AB
A214501-005AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214501-001BRIVARACETAM10MGTABLET / ORAL2022-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214501-002BRIVARACETAM25MGTABLET / ORAL2022-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214501-003BRIVARACETAM50MGTABLET / ORAL2022-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214501-004BRIVARACETAM75MGTABLET / ORAL2022-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214501-005BRIVARACETAM100MGTABLET / ORAL2022-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214501-001BRIVARACETAM10MGTABLET / ORAL2022-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214501-002BRIVARACETAM25MGTABLET / ORAL2022-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214501-003BRIVARACETAM50MGTABLET / ORAL2022-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214501-004BRIVARACETAM75MGTABLET / ORAL2022-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214501-005BRIVARACETAM100MGTABLET / ORAL2022-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A214501-001BRIVARACETAM10MGTABLET / ORAL2022-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214501-002BRIVARACETAM25MGTABLET / ORAL2022-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214501-003BRIVARACETAM50MGTABLET / ORAL2022-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214501-004BRIVARACETAM75MGTABLET / ORAL2022-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214501-005BRIVARACETAM100MGTABLET / ORAL2022-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214501-001BRIVARACETAM10MGTABLET / ORAL2022-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214501-002BRIVARACETAM25MGTABLET / ORAL2022-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214501-003BRIVARACETAM50MGTABLET / ORAL2022-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214501-004BRIVARACETAM75MGTABLET / ORAL2022-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214501-005BRIVARACETAM100MGTABLET / ORAL2022-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214501-001BRIVARACETAM10MGTABLET / ORAL2022-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214501-002BRIVARACETAM25MGTABLET / ORAL2022-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214501-003BRIVARACETAM50MGTABLET / ORAL2022-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214501-004BRIVARACETAM75MGTABLET / ORAL2022-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214501-005BRIVARACETAM100MGTABLET / ORAL2022-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214501-001BRIVARACETAM10MGTABLET / ORAL2022-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214501-002BRIVARACETAM25MGTABLET / ORAL2022-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214501-003BRIVARACETAM50MGTABLET / ORAL2022-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214501-004BRIVARACETAM75MGTABLET / ORAL2022-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214501-005BRIVARACETAM100MGTABLET / ORAL2022-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214501-001BRIVARACETAM10MGTABLET / ORAL2022-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214501-002BRIVARACETAM25MGTABLET / ORAL2022-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214501-003BRIVARACETAM50MGTABLET / ORAL2022-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214501-004BRIVARACETAM75MGTABLET / ORAL2022-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214501-005BRIVARACETAM100MGTABLET / ORAL2022-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214501-001BRIVARACETAM10MGTABLET / ORAL2022-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214501-002BRIVARACETAM25MGTABLET / ORAL2022-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214501-003BRIVARACETAM50MGTABLET / ORAL2022-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214501-004BRIVARACETAM75MGTABLET / ORAL2022-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214501-005BRIVARACETAM100MGTABLET / ORAL2022-10-035bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214501-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214501-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214501-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214501-004AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214501-005AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214501-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A214501-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A214501-003AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A214501-004AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A214501-005AB1f41ea6bd6efb…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214501-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214501-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214501-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214501-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214501-005AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIVARACETAM10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U863JGG2IAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1739761Internal RxNorm lookup
1739768Internal RxNorm lookup
1739772Internal RxNorm lookup
1739776Internal RxNorm lookup
1739780Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d54ca946-2ddf-4a67-87c9-20a814bfd2dcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1447c696-6954-40c0-b275-6f6c780ca8b7Product name120160323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1584-4brivaracetam100 in 1 CARTONTABLET, FILM COATED1004
70710-1584-6brivaracetam60 in 1 BOTTLETABLET, FILM COATED604
70710-1584-7brivaracetam1 in 1 BLISTER PACKTABLET, FILM COATED14
70710-1584-8brivaracetam180 in 1 BOTTLETABLET, FILM COATED1804

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
brivaracetamBRIVARACETAMZydus Lifesciences Limited67c4db20-ba4d-4640-9e9c-6949b85429e32026-01-27Exact identifier
application applno (ANDA): 214501
application number: ANDA214501
brivaracetamBRIVARACETAMZydus Pharmaceuticals USA Inc.d54ca946-2ddf-4a67-87c9-20a814bfd2dc2026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214501
application number: ANDA214501
ndc (product): 70710-1584

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739761brivaracetam 10 MG Oral TabletPSNd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739768brivaracetam 100 MG Oral TabletPSNd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739772brivaracetam 25 MG Oral TabletPSNd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739776brivaracetam 50 MG Oral TabletPSNd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739780brivaracetam 75 MG Oral TabletPSNd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739761brivaracetam 10 MG Oral TabletSCDd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739768brivaracetam 100 MG Oral TabletSCDd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739772brivaracetam 25 MG Oral TabletSCDd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739776brivaracetam 50 MG Oral TabletSCDd54ca946-2ddf-4a67-87c9-20a814bfd2dc4
1739780brivaracetam 75 MG Oral TabletSCDd54ca946-2ddf-4a67-87c9-20a814bfd2dc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1584-470710158404100 BLISTER PACK in 1 CARTON (70710-1584-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK (70710-1584-7) 100 blister pack2026-02-21NoNoCurrent
70710-1584-67071015840660 TABLET, FILM COATED in 1 BOTTLE (70710-1584-6) 2026-02-21NoNoCurrent
70710-1584-7707101584071 in 1 BLISTER PACKHistorical
70710-1584-870710158408180 TABLET, FILM COATED in 1 BOTTLE (70710-1584-8) 2026-02-21NoNoCurrent