brivaracetam

Product NDC
73473-906
11-digit product format
734730906
Labeler code
73473
Product ID
73473-906_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
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214748-001BRIVARACETAMBRIVARACETAM10MGTABLET / ORALAB2022-06-09
A214748-002BRIVARACETAMBRIVARACETAM25MGTABLET / ORALAB2022-06-09
A214748-003BRIVARACETAMBRIVARACETAM50MGTABLET / ORALAB2022-06-09
A214748-004BRIVARACETAMBRIVARACETAM75MGTABLET / ORALAB2022-06-09
A214748-005BRIVARACETAMBRIVARACETAM100MGTABLET / ORALAB2022-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214748-001AB
A214748-002AB
A214748-003AB
A214748-004AB
A214748-005AB

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 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214748-001BRIVARACETAM10MGTABLET / ORALAB2022-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214748-002BRIVARACETAM25MGTABLET / ORALAB2022-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214748-003BRIVARACETAM50MGTABLET / ORALAB2022-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214748-004BRIVARACETAM75MGTABLET / ORALAB2022-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214748-005BRIVARACETAM100MGTABLET / ORALAB2022-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214748-001BRIVARACETAM10MGTABLET / ORAL2022-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214748-002BRIVARACETAM25MGTABLET / ORAL2022-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214748-003BRIVARACETAM50MGTABLET / ORAL2022-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214748-004BRIVARACETAM75MGTABLET / ORAL2022-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214748-005BRIVARACETAM100MGTABLET / ORAL2022-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A214748-001BRIVARACETAM10MGTABLET / ORAL2022-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214748-002BRIVARACETAM25MGTABLET / ORAL2022-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214748-003BRIVARACETAM50MGTABLET / ORAL2022-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214748-004BRIVARACETAM75MGTABLET / ORAL2022-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214748-005BRIVARACETAM100MGTABLET / ORAL2022-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214748-001BRIVARACETAM10MGTABLET / ORAL2022-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214748-002BRIVARACETAM25MGTABLET / ORAL2022-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214748-003BRIVARACETAM50MGTABLET / ORAL2022-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214748-004BRIVARACETAM75MGTABLET / ORAL2022-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214748-005BRIVARACETAM100MGTABLET / ORAL2022-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214748-001BRIVARACETAM10MGTABLET / ORAL2022-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214748-002BRIVARACETAM25MGTABLET / ORAL2022-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214748-003BRIVARACETAM50MGTABLET / ORAL2022-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214748-004BRIVARACETAM75MGTABLET / ORAL2022-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214748-005BRIVARACETAM100MGTABLET / ORAL2022-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214748-001BRIVARACETAM10MGTABLET / ORAL2022-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214748-002BRIVARACETAM25MGTABLET / ORAL2022-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214748-003BRIVARACETAM50MGTABLET / ORAL2022-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214748-004BRIVARACETAM75MGTABLET / ORAL2022-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214748-005BRIVARACETAM100MGTABLET / ORAL2022-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214748-001BRIVARACETAM10MGTABLET / ORAL2022-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214748-002BRIVARACETAM25MGTABLET / ORAL2022-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214748-003BRIVARACETAM50MGTABLET / ORAL2022-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214748-004BRIVARACETAM75MGTABLET / ORAL2022-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214748-005BRIVARACETAM100MGTABLET / ORAL2022-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214748-001BRIVARACETAM10MGTABLET / ORAL2022-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214748-002BRIVARACETAM25MGTABLET / ORAL2022-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214748-003BRIVARACETAM50MGTABLET / ORAL2022-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214748-004BRIVARACETAM75MGTABLET / ORAL2022-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214748-005BRIVARACETAM100MGTABLET / ORAL2022-06-095bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214748-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214748-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214748-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214748-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214748-005AB1011fe1cb6892…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214748-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214748-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214748-003AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214748-004AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214748-005AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214748-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214748-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214748-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214748-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214748-005AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
brivaracetamBRIVARACETAMSolarisPharmaCorporation49f726ec-e51b-7516-e063-6294a90ae6842026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214748
application number: ANDA214748
ndc (product): 73473-906

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIVARACETAM50 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
49f726ec-e51b-7516-e063-6294a90ae684Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
1447c696-6954-40c0-b275-6f6c780ca8b7Product name120160323
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73473-906-60brivaracetam60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73473-906-60EA - Each73473-90622648727-3e47-4109-a116-e36d4a2b570612026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739761brivaracetam 10 MG Oral TabletPSN49f726ec-e51b-7516-e063-6294a90ae6842
1739768brivaracetam 100 MG Oral TabletPSN49f726ec-e51b-7516-e063-6294a90ae6842
1739772brivaracetam 25 MG Oral TabletPSN49f726ec-e51b-7516-e063-6294a90ae6842
1739776brivaracetam 50 MG Oral TabletPSN49f726ec-e51b-7516-e063-6294a90ae6842
1739780brivaracetam 75 MG Oral TabletPSN49f726ec-e51b-7516-e063-6294a90ae6842
1739761brivaracetam 10 MG Oral TabletSCD49f726ec-e51b-7516-e063-6294a90ae6842
1739768brivaracetam 100 MG Oral TabletSCD49f726ec-e51b-7516-e063-6294a90ae6842
1739772brivaracetam 25 MG Oral TabletSCD49f726ec-e51b-7516-e063-6294a90ae6842
1739776brivaracetam 50 MG Oral TabletSCD49f726ec-e51b-7516-e063-6294a90ae6842
1739780brivaracetam 75 MG Oral TabletSCD49f726ec-e51b-7516-e063-6294a90ae6842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73473-906-607347309066060 TABLET, FILM COATED in 1 BOTTLE (73473-906-60) 2026-02-04NoNoCurrent