Buprenex
- Product NDC
- 12496-0757
- 11-digit product format
- 124960757
- Labeler code
- 12496
- Product ID
- 12496-0757_9925737b-3031-4372-a2cf-8c4ed05ebdbf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Indivior Inc.
- Application
- NDA018401
- Marketing category
- NDA
- Marketing start
- 1985-06-30
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- 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
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 12496-0757-5 | 12496075705 | 5 AMPULE in 1 CARTON (12496-0757-5) > 1 mL in 1 AMPULE (12496-0757-1) | 5 ampule | 1985-06-30 | 0000-00-00 | No | No | Current |