Buprenorphine and Naloxone
- Product NDC
- 52427-698
- 11-digit product format
- 524270698
- Labeler code
- 52427
- Product ID
- 52427-698_f5a2bf1e-bf17-cd23-0f0c-88d85a209825
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine and Naloxone
- Dosage form
- FILM
- Route
- BUCCAL; SUBLINGUAL
- Labeler
- Almatica Pharma Inc.
- Application
- ANDA205954
- Marketing category
- ANDA
- Marketing start
- 2019-02-11
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 8 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
- 2022-12-31
- 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 |
|---|
| 52427-698-03 | 52427069803 | 30 POUCH in 1 CARTON (52427-698-03) > 1 FILM in 1 POUCH (52427-698-11) | 30 pouch | 2019-02-11 | 0000-00-00 | No | No | Current |