NDC 71610-132
Carvedilol 3.125 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-142.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Mahabubnagar, India | Makes it and tests it | No problems foundJan 18, 2023 · 2 inspections |
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Nov 15, 2021 · Class III · Aurobindo Pharma USA Inc.
Failed Impurities/Degradation Specifications
Lots: Batch QG0619030-A, exp 11/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Carvedilol: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 3.125 mg
- Approval
- ANDA ANDA078332
- On the market since
- Sep 5, 2007
- Package NDCs
71610-132-5371610-132-6071610-132-80- Official label
- DailyMed (National Library of Medicine), updated Sep 12, 2018
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