NDC 76420-077
Dexamethasone Sodium Phosphate 4 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 55150-237.
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
- May 23, 2024 · Class II · Eugia US LLC
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Lots: Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Dexamethasone: every company that makes it
- Form
- injection, solution, intra-articular; intralesional; intramuscular; intravenous; soft tissue
- Strength
- 4 mg per 1 mL
- Approval
- ANDA ANDA206781
- On the market since
- Feb 11, 2020
- Package NDCs
76420-077-01- Official label
- DailyMed (National Library of Medicine), updated Oct 12, 2022
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