buprenorphine hydrochloride and naloxone hydrochloride
buprenorphine hydrochloride and naloxone hydrochloride is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand names including Zubsolv, Buprenorphine and Naloxone. Available dosage forms: tablet, orally disintegrating, tablet.
Drug Details
- Generic Name
- buprenorphine hydrochloride and naloxone hydrochloride
- Brand Names
- Zubsolv, Buprenorphine and Naloxone
- Application Number
- NDA204242
- Sponsor
- Edenbridge Pharmaceuticals LLC.
- NDC Codes
- 14
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING, TABLET
- Routes
- SUBLINGUAL
- Active Ingredients
- BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
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 part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )