Lupin Limited
Dhar, India · makes it and packages it
Problems found, fixed voluntarily Last FDA inspection Sep 27, 2024. 4 inspections on record.
NDC 82804-314
Levothyroxine Sodium 0.05 mg tablet
On the label: Proficient Rx LP.
It's a repackaged product: Proficient Rx LP rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-966.
Where the pills inside were made
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels it
Recalls
- Dec 20, 2024 · Class II · Terminated
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
Product details
- Generic drug
- Levothyroxine: see every company that makes it
- Form
- tablet, oral
- Strength
- 0.05 mg
- Approval
- ANDA ANDA209713
- On the market since
- May 2, 2019
- Package NDCs
82804-314-30- Official label
- DailyMed (National Library of Medicine), updated Sep 1, 2026
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