Buprenorphine Sublingual C-III
- Product NDC
- 72189-582
- 11-digit product format
- 721890582
- Labeler code
- 72189
- Product ID
- 72189-582_248524c6-4c8c-a450-e063-6394a90a81ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine Sublingual C-III
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Direct_Rx
- Application
- ANDA078633
- Marketing category
- ANDA
- Marketing start
- 2024-10-15
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- 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 |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-582-60 | 72189058260 | 60 TABLET in 1 BOTTLE (72189-582-60) | 60 tablet | 2024-10-15 | No | No | Historical |