NDC 50474-470

Briviact

Brivaracetam

Briviact is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ucb, Inc.. The primary component is Brivaracetam.

• Product ID: 50474-470_708cf16b-de7e-4987-86b4-84c1ca71b76c
• NDC: 50474-470
• Product Type: Human Prescription Drug
• Proprietary Name: Briviact
• Generic Name: Brivaracetam
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-05-12
• Marketing Category: NDA / NDA
• Application Number: NDA205836
• Labeler Name: UCB, Inc.
• Substance Name: BRIVARACETAM
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Epoxide Hydrolase Inhibitors [MoA]
• DEA Schedule: CV
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50474-470-09

100 BLISTER PACK in 1 CARTON (50474-470-09) > 1 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2016-05-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50474-470-66 [50474047066]

Briviact TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205836
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-05-12

NDC 50474-470-09 [50474047009]

Briviact TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205836
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-05-12

NDC 50474-470-12 [50474047012]

Briviact TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205836
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-12
• Marketing End Date: 2019-03-22

NDC 50474-470-14 [50474047014]

Briviact TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205836
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-12

Drug Details

Active Ingredients

Ingredient	Strength
BRIVARACETAM	25 mg/1

OpenFDA Data

• SPL SET ID: 3cf2f439-0e97-443e-8e33-25ecef616f6c
• Manufacturer:
  • UCB, Inc.
• UNII:
  • U863JGG2IA
• RxNorm Concept Unique ID - RxCUI:
  • 1739774
  • 1739761
  • 1739766
  • 1739770
  • 1739772
  • 1739785
  • 1739768
  • 1739780
  • 1739778
  • 1739782
  • 1739749
  • 1739776
  • 1739788
  • 1739754

Pharmacological Class

• Epoxide Hydrolase Inhibitors [MoA]
• Epoxide Hydrolase Inhibitors [MoA]

NDC Crossover Matching brand name "Briviact" or generic name "Brivaracetam"

NDC	Brand Name	Generic Name
50474-370	Briviact	brivaracetam
50474-470	Briviact	brivaracetam
50474-570	Briviact	brivaracetam
50474-670	Briviact	brivaracetam
50474-770	Briviact	brivaracetam
50474-870	Briviact	brivaracetam
50474-970	Briviact	brivaracetam