# Diclofenac Sodium and Misoprostol

NDC: 65162-438
Generic name: Diclofenac Sodium and Misoprostol
Labeler / Manufacturer: Amneal Pharmaceuticals LLC
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET, DELAYED RELEASE
Routes: ORAL
Marketing started: 20161201

FDA application: ANDA203995

## Active ingredients

- DICLOFENAC SODIUM: 75 mg/1
- MISOPROSTOL: 200 ug/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"65162-438"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=65162-438
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=afd30051-8f59-474b-9972-962a5a871dfb