Bupivacaine Hydrochloride
- Product NDC
- 52584-163
- 11-digit product format
- 525840163
- Labeler code
- 52584
- Product ID
- 52584-163_3d03c317-10a2-48a8-952e-9c8574923ddc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bupivacaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- PERINEURAL
- Labeler
- General Injectables & Vaccines, Inc
- Application
- ANDA070597
- Marketing category
- ANDA
- Marketing start
- 2010-07-01
- Marketing end
- 2023-11-01
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-163-01 | 52584016301 | 1 VIAL, MULTI-DOSE in 1 BAG (52584-163-01) > 50 mL in 1 VIAL, MULTI-DOSE | 2010-07-01 | 2023-11-01 | No | No | Current |