NDC 82804-246
Levothyroxine Sodium 0.125 mg tablet
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-971.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Dhar, India | Makes it and packages it | Problems found, fixed voluntarilySep 27, 2024 · 4 inspections |
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels it
Recalls
- Dec 20, 2024 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Lots: Lot# LA01276, Exp Date: 07/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Levothyroxine: every company that makes it
- Form
- tablet, oral
- Strength
- 0.125 mg
- Approval
- ANDA ANDA209713
- On the market since
- Mar 20, 2019
- Package NDCs
82804-246-30- Official label
- DailyMed (National Library of Medicine), updated Oct 1, 2025
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