Buprenorphine and Naloxone
- Product NDC
- 70518-3603
- 11-digit product format
- 705183603
- Labeler code
- 70518
- Product ID
- 70518-3603_f1dbd7c6-eef7-41ad-e053-2a95a90ace02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA201633
- Marketing category
- ANDA
- Marketing start
- 2023-01-04
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 2 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
- 2024-12-31
- 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 |
|---|
| 70518-3603-0 | 70518360300 | 30 TABLET in 1 BLISTER PACK (70518-3603-0) | 30 tablet | 2023-01-04 | 0000-00-00 | No | No | Current |