NDC 0904-6822
Entacapone 200 mg tablet, film coated
On the label: Major Pharmaceuticals. It's repackaged: Major Pharmaceuticals rebottles it from Aurobindo Pharma Limited's NDC 65862-654.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Jul 29, 2021 · Class II · The Harvard Drug Group
Failed Dissolution Specifications
Lots: Lot, expiry: N00187, 05/2022; N00245, 06/2022; N00273, 07/2022; N00355, 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
- Entacapone: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 200 mg
- Approval
- ANDA ANDA203437
- On the market since
- Jun 19, 2015
- Package NDCs
0904-6822-040904-6822-07- Official label
- DailyMed (National Library of Medicine), updated Sep 10, 2025
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