Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
- Product NDC
- 51862-608
- 11-digit product format
- 518620608
- Labeler code
- 51862
- Product ID
- 51862-608_2b0ecf1b-9053-4464-a883-278c78238c5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA206953
- Marketing category
- ANDA
- Marketing start
- 2021-05-28
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51862-608-30 | 51862060830 | 30 TABLET in 1 BOTTLE (51862-608-30) | 30 tablet | 2021-05-28 | 0000-00-00 | No | No | Current |