NDC 16571-692
Carbidopa, Levodopa And Entacapone 125 mg / 200 mg / 31.25 mg tablet, film coated
On the label: Rising Pharma Holdings, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cohance Lifesciences Limited | Sangareddy, India | Makes it, makes the active ingredient, tests it, packages it and labels it | No problems foundFeb 23, 2024 · 7 inspections |
Recalls
- Oct 7, 2025 · Class II · Rising Pharma Holding, Inc.
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Lots: Lot # CS25070, exp. date 03/31/2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Carbidopa and Entacapone and Levodopa: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 125 mg / 200 mg / 31.25 mg
- Approval
- ANDA ANDA213212
- On the market since
- Aug 5, 2021
- Package NDCs
16571-692-01- Official label
- DailyMed (National Library of Medicine), updated Apr 8, 2026
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