buprenorphine

FDA Drug Profile — Butrans, SUBLOCADE, buprenorphine transdermal system

buprenorphine is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand names including Butrans, SUBLOCADE, buprenorphine transdermal system. Available dosage forms: patch, extended release, solution.

Drug Details

Generic Name
buprenorphine
Brand Names
Butrans, SUBLOCADE, buprenorphine transdermal system
Application Number
NDA021306
Sponsor
Knoa Pharma LLC
NDC Codes
14
Dosage Forms
PATCH, EXTENDED RELEASE, SOLUTION
Routes
TRANSDERMAL, SUBCUTANEOUS
Active Ingredients
BUPRENORPHINE

Indications and Usage

1 INDICATIONS AND USAGE Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are 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 contain 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 )