buprenorphine and naloxone

FDA Drug Profile — Buprenorphine and Naloxone

buprenorphine and naloxone is listed in the FDA National Drug Code directory with 13 NDC codes, marketed under brand name including Buprenorphine and Naloxone. Available dosage forms: film, film, soluble.

Drug Details

Generic Name
buprenorphine and naloxone
Brand Names
Buprenorphine and Naloxone
Application Number
ANDA212756
Sponsor
Redpharm Drug
NDC Codes
13
Dosage Forms
FILM, FILM, SOLUBLE
Routes
BUCCAL, SUBLINGUAL
Active Ingredients
BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Buprenorphine and naloxone sublingual tablets are indicated for maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence. ( 1 ) Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )