NDC 53002-5893
Benzonatate 100 mg capsule
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Strides Pharma Science Limited's NDC 64380-712.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Strides Pharma Science Limited | Bengaluru, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyMay 20, 2026 · 11 inspections |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- May 9, 2017 · Class III · Strides Pharma INC
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Lots: Lot #: 7225075, 7225076, 7225077, 7225078, 7225079, 7225080 Exp 7/2017; 7225180, 7225181, 7225322, 7225323, Exp 8/2017; 7225649A, 7225650A , 7225651A , 7225652A, 7225653A, 7225654A, Exp 9/2017
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
- Strength
- 100 mg
- Approval
- ANDA ANDA091133
- On the market since
- Dec 10, 2016
- Package NDCs
53002-5893-153002-5893-253002-5893-353002-5893-5- Official label
- DailyMed (National Library of Medicine), updated Aug 7, 2023
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