FDA.reportPublic FDA data

Briviact

Product NDC
50474-970
11-digit product format
504740970
Labeler code
50474
Product ID
50474-970_51b3e2db-678a-dd8b-e063-6394a90aed7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brivaracetam
Dosage form
INJECTION, SUSPENSION
Route
INTRAVENOUS
Labeler
UCB, Inc.
Application
NDA205837
Marketing category
NDA
Marketing start
2016-05-12
Substance
BRIVARACETAM
Active strength
50 mg/5mL
Pharmacologic classes
Epoxide Hydrolase Inhibitors [MoA]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIVARACETAM50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU863JGG2IA
Rxcui1739749, 1739754, 1739761, 1739766, 1739768, 1739770, 1739772, 1739774, 1739776, 1739778, 1739780, 1739782, 1739785, 1739788

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
1447c696-6954-40c0-b275-6f6c780ca8b7Product name120160323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50474-970-63Briviact5 mL in 1 VIAL, GLASSINJECTION, SUSPENSION526
50474-970-75Briviact10 in 1 CARTONINJECTION, SUSPENSION1026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50474-970BRIVIACT (BRIVARACETAM) TABLET, FILM COATED BRIVIACT (BRIVARACETAM) SOLUTION BRIVIACT (BRIVARACETAM) INJECTION, SUSPENSION [UCB, INC.]19Current NDC, Legacy NDC, 2 package rows20230526_3cf2f439-0e97-443e-8e33-25ecef616f6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739785brivaracetam 10 MG in 1 mL Oral SolutionPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739761brivaracetam 10 MG Oral TabletPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739768brivaracetam 100 MG Oral TabletPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739772brivaracetam 25 MG Oral TabletPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739749brivaracetam 50 MG in 5 ML InjectionPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739776brivaracetam 50 MG Oral TabletPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739780brivaracetam 75 MG Oral TabletPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739788BRIVIACT 10 MG in 1 mL Oral SolutionPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739766Briviact 10 MG Oral TabletPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739770Briviact 100 MG Oral TabletPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739774Briviact 25 MG Oral TabletPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739754Briviact 50 MG in 5 ML InjectionPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739778Briviact 50 MG Oral TabletPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739782Briviact 75 MG Oral TabletPSN3cf2f439-0e97-443e-8e33-25ecef616f6c26
17397545 ML brivaracetam 10 MG/ML Injection [Briviact]SBD3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739766brivaracetam 10 MG Oral Tablet [Briviact]SBD3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739788brivaracetam 10 MG/ML Oral Solution [Briviact]SBD3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739770brivaracetam 100 MG Oral Tablet [Briviact]SBD3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739774brivaracetam 25 MG Oral Tablet [Briviact]SBD3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739778brivaracetam 50 MG Oral Tablet [Briviact]SBD3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739782brivaracetam 75 MG Oral Tablet [Briviact]SBD3cf2f439-0e97-443e-8e33-25ecef616f6c26
17397495 ML brivaracetam 10 MG/ML InjectionSCD3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739761brivaracetam 10 MG Oral TabletSCD3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739785brivaracetam 10 MG/ML Oral SolutionSCD3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739768brivaracetam 100 MG Oral TabletSCD3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739772brivaracetam 25 MG Oral TabletSCD3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739776brivaracetam 50 MG Oral TabletSCD3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739780brivaracetam 75 MG Oral TabletSCD3cf2f439-0e97-443e-8e33-25ecef616f6c26
17397545 ML Briviact 10 MG/ML InjectionSY3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739785brivaracetam 10 MG per 1 ML Oral SolutionSY3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739749brivaracetam 50 MG per 5 ML InjectionSY3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739766Briviact 10 MG Oral TabletSY3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739788Briviact 10 MG per 1 ML Oral SolutionSY3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739770Briviact 100 MG Oral TabletSY3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739774Briviact 25 MG Oral TabletSY3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739778Briviact 50 MG Oral TabletSY3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739754Briviact 50 MG per 5 ML InjectionSY3cf2f439-0e97-443e-8e33-25ecef616f6c26
1739782Briviact 75 MG Oral TabletSY3cf2f439-0e97-443e-8e33-25ecef616f6c26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50474-970-63504740970635 mL in 1 VIAL, GLASS5 mlHistorical
50474-970-755047409707510 VIAL, GLASS in 1 CARTON (50474-970-75) / 5 mL in 1 VIAL, GLASS (50474-970-63) 2016-05-120000-00-00NoNoCurrent