buprenorphine hydrochloride and naloxone hydrochloride dihydrate
buprenorphine hydrochloride and naloxone hydrochloride dihydrate is listed in the FDA National Drug Code directory with 12 NDC codes, marketed under brand name including buprenorphine hydrochloride and naloxone hydrochloride dihydrate. Available dosage form: tablet.
Drug Details
- Generic Name
- buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Brand Names
- buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Application Number
- ANDA203326
- Sponsor
- Hikma Pharmaceuticals USA Inc.
- NDC Codes
- 12
- Dosage Forms
- TABLET
- Routes
- SUBLINGUAL
- Active Ingredients
- BUPRENORPHINE HYDROCHLORIDE, 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 part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )