Naloxone

FDA Drug Profile — Naloxone Hydrochloride

Naloxone is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Naloxone Hydrochloride. Available dosage forms: powder, spray.

Drug Details

Generic Name
Naloxone
Brand Names
Naloxone Hydrochloride
Application Number
ANDA217992
Sponsor
Pharmaron Manufacturing Services (UK) Ltd
NDC Codes
2
Dosage Forms
POWDER, SPRAY
Routes
NASAL
Active Ingredients
NALOXONE HYDROCHLORIDE DIHYDRATE, 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 )