buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Product NDC
- 70518-3862
- 11-digit product format
- 705183862
- Labeler code
- 70518
- Product ID
- 70518-3862_422983e3-7c40-32e6-e063-6294a90ae95d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203326
- Marketing category
- ANDA
- Marketing start
- 2023-09-15
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 2; .5 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 56W8MW3EN1 | BUPRENORPHINE HYDROCHLORIDE | 53152-21-9 | BUPRENORPHINE HYDROCHLORIDE |
| 5Q187997EE | NALOXONE HYDROCHLORIDE DIHYDRATE | 51481-60-8 | NALOXONE HYDROCHLORIDE DIHYDRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3862-0 | 70518386200 | 30 TABLET in 1 BLISTER PACK (70518-3862-0) | 30 tablet | 2023-09-15 | No | No | Historical |