buprenorphine hydrochloride

FDA Drug Profile — buprenorphine hydrochloride, BELBUCA

buprenorphine hydrochloride is listed in the FDA National Drug Code directory with 19 NDC codes, marketed under brand names including buprenorphine hydrochloride, BELBUCA. Available dosage forms: tablet, film, soluble.

Drug Details

Generic Name
buprenorphine hydrochloride
Brand Names
buprenorphine hydrochloride, BELBUCA
Application Number
ANDA090279
Sponsor
Advagen Pharma Ltd
NDC Codes
19
Dosage Forms
TABLET, FILM, SOLUBLE
Routes
SUBLINGUAL, BUCCAL
Active Ingredients
BUPRENORPHINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Buprenorphine sublingual tablets is indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablets contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction. ( 1 ) Buprenorphine sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support ( 1 ).