Buprenorphine and Naloxone
- Product NDC
- 70518-2311
- 11-digit product format
- 705182311
- Labeler code
- 70518
- Product ID
- 70518-2311_db5d89ee-fc14-1f7a-e053-2995a90a7365
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA205022
- Marketing category
- ANDA
- Marketing start
- 2019-09-12
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE; NALOXONE
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 70518-2311-0 | 70518231100 | 30 TABLET in 1 BLISTER PACK (70518-2311-0) | 30 tablet | 2019-09-12 | 0000-00-00 | No | No | Current |