NDC 10135-748
Digoxin 0.25 mg tablet
On the label: Marlex Pharmaceuticals, Inc.. It's repackaged: Marlex Pharmaceuticals, Inc. rebottles it from ANI Pharmaceuticals, Inc.'s NDC 70954-202.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Novitium Pharma LLC | East Windsor, NJ, United States | Makes it, tests it, packages it and labels it | No problems foundFeb 16, 2024 · 5 inspections |
Recalls
- Mar 25, 2024 · Class III · Novitium Pharma LLC
Failed Impurities/Degradation Specifications
Lots: Lot M23011A; Exp. 12/2024 - Mar 4, 2024 · Class III · Novitium Pharma LLC
Cross Contamination with Other Products:(mycophenolate mofetil).
Lots: Lot #: M23172A, Exp 01/31/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Digoxin: every company that makes it
- Form
- tablet, oral
- Strength
- 0.25 mg
- Approval
- ANDA ANDA215307
- On the market since
- Jun 1, 2022
- Package NDCs
10135-748-0110135-748-10- Official label
- DailyMed (National Library of Medicine), updated Nov 4, 2026
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