NDC 47335-678
Diltiazem Hydrochloride 300 mg capsule, extended release
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Halol, India | Makes it and tests it | Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action |
Recalls
- Jan 13, 2023 · Class II · Sun Pharmaceutical Industries Inc
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Lots: Lot #: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024.
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, extended release, oral
- Strength
- 300 mg
- Approval
- ANDA ANDA090492
- On the market since
- Oct 31, 2011
- Package NDCs
47335-678-1347335-678-1847335-678-1947335-678-8147335-678-83- Official label
- DailyMed (National Library of Medicine), updated Jan 9, 2023
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