Naloxone Hydrochloride dihydrate

FDA Drug Profile

Drug Details

Generic Name
Naloxone Hydrochloride dihydrate
Brand Names
N/A
Application Number
Sponsor
SUN PHARMACEUTICAL INDUSTRIES, INC.
NDC Codes
1
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
NALOXONE HYDROCHLORIDE DIHYDRATE

Indications and Usage

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