NDC 10544-190
Carvedilol 12.5 mg tablet, film coated
On the label: Blenheim Pharmacal, Inc.. It's repackaged: Blenheim Pharmacal, Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-144.
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
- Blenheim Pharmacal, Inc., North Blenheim, New York, United States · repackages it and relabels 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
- Strength
- 12.5 mg
- Approval
- ANDA ANDA078332
- On the market since
- Nov 15, 2013
- Package NDCs
10544-190-3010544-190-8110544-190-90- Official label
- DailyMed (National Library of Medicine), updated Feb 17, 2015
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