Buprenorphine and Naloxone
- Product NDC
- 60429-587
- 11-digit product format
- 604290587
- Labeler code
- 60429
- Product ID
- 60429-587_e64cb42d-75be-4157-e053-2995a90ab1a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride and naloxone hydrochloride
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA204431
- Marketing category
- ANDA
- Marketing start
- 2015-10-16
- Marketing end
- 2023-09-30
- 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
- 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 |
|---|
| 60429-587-30 | 60429058730 | 30 TABLET in 1 BOTTLE, PLASTIC (60429-587-30) | 30 tablet | 2016-01-19 | 0000-00-00 | No | No | Current |