Buprenorphine and Naloxone
- Product NDC
- 63629-9483
- 11-digit product format
- 636299483
- Labeler code
- 63629
- Product ID
- 63629-9483_6529cd98-61bf-430c-8001-c591d52dfa23
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205601
- Marketing category
- ANDA
- Marketing start
- 2020-04-13
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 8; 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
- 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 |
|---|
| 63629-9483-1 | 63629948301 | 30 TABLET in 1 BOTTLE, PLASTIC (63629-9483-1) | 30 tablet | 2022-12-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Buprenorphine and Naloxone | Bryant Ranch Prepack | 2024-01-12 | HUMAN PRESCRIPTION DRUG LABEL | 102 |