Bupivacaine Hydrochloride
- Product NDC
- 76420-561
- 11-digit product format
- 764200561
- Labeler code
- 76420
- Product ID
- 76420-561_028b204a-e3a0-ea94-e063-6294a90ad70e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupivacaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INTRACAUDAL; PERINEURAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA204842
- Marketing category
- ANDA
- Marketing start
- 2021-02-11
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 7TQO7W3VT8 | BUPIVACAINE HYDROCHLORIDE | 73360-54-0 | BUPIVACAINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-561-10 | 76420056110 | 10 mL in 1 VIAL, SINGLE-DOSE (76420-561-10) | 10 ml | 2023-08-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Bupivacaine Hydrochloride | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2023-08-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |