NDC 76420-008
Bupivacaine Hydrochloride 5 mg per 1 mL injection, solution
On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. rebottles it from AuroMedics Pharma LLC's NDC 55150-169.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Eugia Pharma Specialities Limited | Sangareddy, India | Makes it, tests it and packages it | Serious problems, FDA actionFeb 6, 2026 · 7 inspections, 2 with FDA action |
Repackaging site
- Asclemed USA Inc. dba Enovachem, Torrance, CA, United States · relabels it
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Bupivacaine: every company that makes it
- Form
- injection, solution, epidural; intracaudal
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA203895
- On the market since
- Nov 5, 2013
- Package NDCs
76420-008-10- Official label
- DailyMed (National Library of Medicine), updated Oct 12, 2022
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