NDC 61919-400
Benzonatate 100 mg capsule
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-247.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Dec 23, 2014 · Class II · Zydus Pharmaceuticals USA Inc
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Lots: Lot #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Benzonatate: every company that makes it
- Form
- capsule, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA040597
- On the market since
- Mar 12, 2018
- Package NDCs
61919-400-2061919-400-30- Official label
- DailyMed (National Library of Medicine), updated Feb 17, 2025
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