Buprenorphine and Naloxone
- Product NDC
- 60505-7054
- 11-digit product format
- 605057054
- Labeler code
- 60505
- Product ID
- 60505-7054_693c474a-0b87-3adb-f68a-e5e1e33d6e1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine and naloxone
- Dosage form
- FILM
- Route
- BUCCAL; SUBLINGUAL
- Labeler
- Apotex Corp.
- Application
- ANDA212756
- Marketing category
- ANDA
- Marketing start
- 2022-12-12
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Active strength
- 12 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
- 2023-12-31
- 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 |
|---|
| 60505-7054-5 | 60505705405 | 30 POUCH in 1 CARTON (60505-7054-5) > 1 FILM in 1 POUCH (60505-7054-0) | 30 pouch | 2022-06-03 | 0000-00-00 | No | No | Current |