NDC 0591-0397
Diclofenac Sodium and Misoprostol 50 mg / 200 ug tablet, delayed release
On the label: Actavis Pharma, Inc..
Where it's made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Actavis Pharma, Inc. names for other drugs.
Recalls
- Apr 24, 2014 · Class II · Actavis Laboratories, FL, Inc.
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Lots: Lot #: 660513A, Exp. 10/31/2014
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, oral
- Strength
- 50 mg / 200 ug
- Approval
- ANDA ANDA201089
- On the market since
- Nov 1, 2012
- Package NDCs
0591-0397-190591-0397-60- Official label
- DailyMed (National Library of Medicine), updated May 1, 2025
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