Buprenorphine Hydrochloride
- Product NDC
- 0517-0725
- 11-digit product format
- 005170725
- Labeler code
- 0517
- Product ID
- 0517-0725_dd6bfd50-a4f5-4738-8b8e-14058f2b9fb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- American Regent, Inc.
- Application
- ANDA078331
- Marketing category
- ANDA
- Marketing start
- 2010-08-13
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 0517-0725-05 | 00517072505 | 5 VIAL in 1 CARTON (0517-0725-05) > 1 mL in 1 VIAL (0517-0725-01) | 5 vial | 2010-08-13 | 0000-00-00 | No | No | Current |