BUNAVAIL
- Product NDC
- 59385-014
- 11-digit product format
- 593850014
- Labeler code
- 59385
- Product ID
- 59385-014_c7062763-9958-49c8-a0a3-e61d5b947b27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine and naloxone
- Dosage form
- FILM
- Route
- BUCCAL
- Labeler
- BioDelivery Sciences International, Inc.
- Application
- NDA205637
- Marketing category
- NDA
- Marketing start
- 2014-09-30
- Marketing end
- 2021-10-31
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 4 mg/1; mg/1
- Pharmacologic classes
- Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| 59385-014-30 | 59385001430 | 30 POUCH in 1 BOX (59385-014-30) > 1 FILM in 1 POUCH (59385-014-01) | 30 pouch | 2014-09-30 | 2021-10-31 | No | No | Current |