BUNAVAIL
- Product NDC
- 59385-012
- 11-digit product format
- 593850012
- Labeler code
- 59385
- Product ID
- 59385-012_d1c1f84c-1c2c-4ece-9137-60a5eb582427
- 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
- 2021-02-28
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 2 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 |
|---|
| 59385-012-30 | 59385001230 | 30 POUCH in 1 BOX (59385-012-30) > 1 FILM in 1 POUCH (59385-012-01) | 30 pouch | 2014-09-30 | 2021-02-28 | No | No | Current |