Buprenorphine and Naloxone
- Product NDC
- 50383-287
- 11-digit product format
- 503830287
- Labeler code
- 50383
- Product ID
- 50383-287_2a09fa37-561b-4c07-a2a7-bf5ed2c5f1aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride and naloxone hydrochloride
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Akorn Operating Company LLC (dba Akorn)
- Application
- ANDA204431
- Marketing category
- ANDA
- Marketing start
- 2016-01-07
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Active strength
- 8 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
DailyMed Product Concepts#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50383-287-93 | 50383028793 | 30 TABLET in 1 BOTTLE, PLASTIC (50383-287-93) | 30 tablet | 2016-01-07 | 0000-00-00 | No | No | Current |