50474-470 : Briviact 25 mg Oral Tablet, Film Coated


NDC: 50474-470
Labeler: Ucb, Inc.
Product Type: Human Prescription Drug
Drug Name:  Briviact
Dosage Form: Oral Tablet, Film Coated
Application #: NDA205836
Rev. Date: 
CSA Schedule: CV (US) [1]


[1] Schedule V Controlled Substance: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. (i.e. Cough preparations containing not more than 200 milligrams of Codeine per 100 milliliters or per 100 grams [such as Robitussin AC, Phenergan with Codeine], and Ezogabine). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: u25
Shapes:  Oval
Colors:  Gray
Size (mm): 9
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 50474-470-09: 100 BLISTER PACK IN 1 CARTON (50474‑470‑09) > 1 TABLET, FILM COATED IN 1 BLISTER PACK
  • 50474-470-12: 5 CARTON IN 1 CARTON (50474‑470‑12) > 2 BLISTER PACK IN 1 CARTON > 14 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

Active Ingredients:

  • Brivaracetam

Dosage Strength:

  • 25 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Lactose Monohydrate
  • Betadex
  • Anhydrous Lactose
  • Magnesium Stearate
  • Polyvinyl Alcohol
  • Talc
  • Polyethylene Glycol 3350
  • Titanium Dioxide
  • Ferric Oxide Yellow
  • Ferrosoferric Oxide

Pharmaceutical Classes:

  • Epoxide Hydrolase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 50474-370 Briviact 10 mg Oral Tablet, Film Coated by Ucb, Inc.
  • 50474-570 Briviact 50 mg Oral Tablet, Film Coated by Ucb, Inc.
  • 50474-670 Briviact 75 mg Oral Tablet, Film Coated by Ucb, Inc.
  • 50474-770 Briviact 100 mg Oral Tablet, Film Coated by Ucb, Inc.
  • 50474-870 Briviact 10 mg/ml Oral Solution by Ucb, Inc.
  • 50474-970 Briviact 50 mg/5ml Intravenous Injection, Suspension by Ucb, Inc.

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.