NDC 72189-574
Doxepin HCL 10 mg capsule
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Alembic Pharmaceuticals Inc.'s NDC 62332-637.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alembic Pharmaceuticals Limited | Panchmahal, India | Makes it | No problems foundJul 26, 2024 · 8 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Jul 25, 2025 · Class II · Alembic Pharmaceuticals Limited
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lots: Lot: 2305015142, Exp. Date: 9/30/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Doxepin: every company that makes it
- Form
- capsule, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA215076
- On the market since
- Sep 10, 2024
- Package NDCs
72189-574-30- Official label
- DailyMed (National Library of Medicine), updated Sep 10, 2024
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