NDC 68682-521
Diltiazem HCl CD 360 mg capsule, coated, extended release
On the label: Oceanside Pharmaceuticals..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Bausch Health Companies Inc. | Steinbach, Canada | Makes it | No problems foundMay 19, 2023 · 6 inspections |
Recalls
- Jan 30, 2019 · Class III · Valeant Pharmaceuticals North America LLC
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Lots: Lots: 18J035P, 18K094P, 18K093P, Exp 09/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Diltiazem: every company that makes it
- Form
- capsule, coated, extended release
- Strength
- 360 mg
- Approval
- NDA NDA020062
- On the market since
- Apr 11, 2001
- Package NDCs
68682-521-01- Official label
- DailyMed (National Library of Medicine), updated Apr 1, 2020
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