brivaracetam

Product NDC
73190-074
11-digit product format
731900074
Labeler code
73190
Product ID
73190-074_5115cab3-6f99-9a71-e063-6294a90a694f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brivaracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA214921
Marketing category
ANDA
Marketing start
2026-05-05
Substance
BRIVARACETAM
Active strength
25 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
A214921-001BRIVARACETAMBRIVARACETAM10MGTABLET / ORALAB2025-11-13
A214921-002BRIVARACETAMBRIVARACETAM25MGTABLET / ORALAB2025-11-13
A214921-003BRIVARACETAMBRIVARACETAM50MGTABLET / ORALAB2025-11-13
A214921-004BRIVARACETAMBRIVARACETAM75MGTABLET / ORALAB2025-11-13
A214921-005BRIVARACETAMBRIVARACETAM100MGTABLET / ORALAB2025-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214921-001AB
A214921-002AB
A214921-003AB
A214921-004AB
A214921-005AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214921-001BRIVARACETAM10MGTABLET / ORALAB2025-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214921-002BRIVARACETAM25MGTABLET / ORALAB2025-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214921-003BRIVARACETAM50MGTABLET / ORALAB2025-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214921-004BRIVARACETAM75MGTABLET / ORALAB2025-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214921-005BRIVARACETAM100MGTABLET / ORALAB2025-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214921-001BRIVARACETAM10MGTABLET / ORALAB2025-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214921-002BRIVARACETAM25MGTABLET / ORALAB2025-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214921-003BRIVARACETAM50MGTABLET / ORALAB2025-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214921-004BRIVARACETAM75MGTABLET / ORALAB2025-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214921-005BRIVARACETAM100MGTABLET / ORALAB2025-11-1331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214921-001BRIVARACETAM10MGTABLET / ORALAB2025-11-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214921-002BRIVARACETAM25MGTABLET / ORALAB2025-11-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214921-003BRIVARACETAM50MGTABLET / ORALAB2025-11-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214921-004BRIVARACETAM75MGTABLET / ORALAB2025-11-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214921-005BRIVARACETAM100MGTABLET / ORALAB2025-11-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214921-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214921-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214921-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214921-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214921-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214921-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214921-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214921-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214921-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214921-005AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214921-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214921-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214921-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214921-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214921-005AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIVARACETAM25 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
5115c5b4-7a23-89f2-e063-6294a90a222aAvailable 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
73190-074-60brivaracetam60 in 1 BOTTLETABLET, FILM COATED601

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
brivaracetamBRIVARACETAMAvKARE5115c5b4-7a23-89f2-e063-6294a90a222a2026-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214921
application number: ANDA214921
ndc (product): 73190-074
brivaracetamBRIVARACETAMNovadoz Pharmaceuticals LLC11ca0e1d-1c0d-4357-9ebd-ee1e87185dde2025-11-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214921
application number: ANDA214921

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739768brivaracetam 100 MG Oral TabletPSN5115c5b4-7a23-89f2-e063-6294a90a222a1
1739772brivaracetam 25 MG Oral TabletPSN5115c5b4-7a23-89f2-e063-6294a90a222a1
1739776brivaracetam 50 MG Oral TabletPSN5115c5b4-7a23-89f2-e063-6294a90a222a1
1739780brivaracetam 75 MG Oral TabletPSN5115c5b4-7a23-89f2-e063-6294a90a222a1
1739768brivaracetam 100 MG Oral TabletSCD5115c5b4-7a23-89f2-e063-6294a90a222a1
1739772brivaracetam 25 MG Oral TabletSCD5115c5b4-7a23-89f2-e063-6294a90a222a1
1739776brivaracetam 50 MG Oral TabletSCD5115c5b4-7a23-89f2-e063-6294a90a222a1
1739780brivaracetam 75 MG Oral TabletSCD5115c5b4-7a23-89f2-e063-6294a90a222a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73190-074-607319000746060 TABLET, FILM COATED in 1 BOTTLE (73190-074-60) 2026-05-05NoNoCurrent