Buprenorphine HCl and Naloxone HCl
- Product NDC
- 70518-1684
- 11-digit product format
- 705181684
- Labeler code
- 70518
- Product ID
- 70518-1684_962aa4c7-f2d0-fd43-e053-2995a90a7572
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203136
- Marketing category
- ANDA
- Marketing start
- 2018-11-21
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record