United States · FDA National Drug Code directory
Diclofenac Sodium and Misoprostol
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 65162-438_0426969f-80c3-4157-b42a-ad57d204d011
- Product NDC
- 65162-438
- Form
- TABLET, DELAYED RELEASE
- Composition / generic term
- Diclofenac Sodium and Misoprostol
- Labeler
- Amneal Pharmaceuticals LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20161201
- Source listing expiry
- 20271231
Source-listed ingredients
- DICLOFENAC SODIUM — 75 mg/1
- MISOPROSTOL — 200 ug/1
These values do not establish equivalence or a dose recommendation.
Packages
- 30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-03) · 65162-438-03
- 60 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-06) · 65162-438-06
- 100 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-10) · 65162-438-10
Source and coverage
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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
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