NDC 10544-955
Diclofenac Sodium and MisoprostolDelayed-Release 75 mg / 0.2 mg tablet, delayed release
On the label: Blenheim Pharmacal, Inc.. It's repackaged: Blenheim Pharmacal, Inc. rebottles it from Eagle Pharmaceuticals, Inc.'s NDC 42367-111.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cipla Limited | Salcette, India | Makes it | Problems found, fixed voluntarilyJun 21, 2024 · 12 inspections, 2 with FDA action |
Repackaging site
- Blenheim Pharmacal, Inc., North Blenheim, New York, United States · repackages it
Recalls
- Apr 20, 2018 · Class II · Exela Pharma Sciences LLC
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Lots: Lot: GH70154, Exp 12/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Diclofenac and Misoprostol: every company that makes it
- Form
- tablet, delayed release
- Strength
- 75 mg / 0.2 mg
- Approval
- ANDA ANDA200540
- On the market since
- Jul 15, 2014
- Package NDCs
10544-955-14- Official label
- DailyMed (National Library of Medicine), updated May 2, 2016
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