Buprenorphine hydrochloride
- Product NDC
- 68083-696
- 11-digit product format
- 680830696
- Labeler code
- 68083
- Product ID
- 68083-696_47e07da7-bfd9-42ea-89dd-b814f546add3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA221145
- Marketing category
- ANDA
- Marketing start
- 2026-10-15
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- .324 mg/mL
- Pharmacologic classes
- Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Buprenorphine hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | .324 mg/mL |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-696-05 | 68083069605 | 5 VIAL in 1 CARTON (68083-696-05) / 1 mL in 1 VIAL | 5 vial | 2026-10-15 | No | No | Current |