briviact

Generic: brivaracetam

Labeler: ucb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name briviact
Generic Name brivaracetam
Labeler ucb, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

brivaracetam 25 mg/1

Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 50474-470
Product ID 50474-470_4c4ad01c-81d3-693d-e063-6294a90ab6c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205836
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 2016-05-12

Pharmacologic Class

Mechanism of Action
epoxide hydrolase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50474470
Hyphenated Format 50474-470

Supplemental Identifiers

RxCUI
1739749 1739754 1739761 1739766 1739768 1739770 1739772 1739774 1739776 1739778 1739780 1739782 1739785 1739788
UNII
U863JGG2IA
NUI
N0000192345

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name briviact (source: ndc)
Generic Name brivaracetam (source: ndc)
Application Number NDA205836 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (50474-470-09) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (50474-470-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (50474-470-66) / 60 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

50474-470-09 100 BLISTER PACK in 1 CARTON (50474-470-09) / 1 TABLET, FILM COATED in 1 BLISTER PACK 50474-470-14 1 BLISTER PACK in 1 CARTON (50474-470-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK 50474-470-66 1 BOTTLE in 1 CARTON (50474-470-66) / 60 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

brivaracetam (25 mg/1)

Linked Drug Pages (1)

Briviact ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c4ad01c-81d3-693d-e063-6294a90ab6c8", "openfda": {"nui": ["N0000192345"], "unii": ["U863JGG2IA"], "rxcui": ["1739749", "1739754", "1739761", "1739766", "1739768", "1739770", "1739772", "1739774", "1739776", "1739778", "1739780", "1739782", "1739785", "1739788"], "spl_set_id": ["3cf2f439-0e97-443e-8e33-25ecef616f6c"], "pharm_class_moa": ["Epoxide Hydrolase Inhibitors [MoA]"], "manufacturer_name": ["UCB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (50474-470-09)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50474-470-09", "marketing_start_date": "20160512"}, {"sample": true, "description": "1 BLISTER PACK in 1 CARTON (50474-470-14)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50474-470-14", "marketing_start_date": "20160512"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50474-470-66)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50474-470-66", "marketing_start_date": "20160512"}], "brand_name": "Briviact", "product_id": "50474-470_4c4ad01c-81d3-693d-e063-6294a90ab6c8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Epoxide Hydrolase Inhibitors [MoA]"], "product_ndc": "50474-470", "dea_schedule": "CV", "generic_name": "brivaracetam", "labeler_name": "UCB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Briviact", "active_ingredients": [{"name": "BRIVARACETAM", "strength": "25 mg/1"}], "application_number": "NDA205836", "marketing_category": "NDA", "marketing_start_date": "20160512", "listing_expiration_date": "20271231"}