DailyMed label

Diclofenac Sodium and Misoprostol

DailyMed label · Actavis Pharma, Inc. · version 38

Key facts

Product Diclofenac Sodium and Misoprostol
Labeler Actavis Pharma, Inc.
Document type HUMAN PRESCRIPTION DRUG LABEL
Active ingredients DICLOFENAC SODIUM, MISOPROSTOL
Active ingredient UNIIs 0E43V0BB57, QTG126297Q
Application number 201089
Route ORAL
NDC package codes 0591-0397-60, 0591-0397-19, 0591-0398-60
Effective date Aug 31, 2026
Set ID df8b8660-0c24-4848-8bea-c1b935090c66

At a glance

  • 1–9 NDC package codes
  • 1–9 Active ingredients
  • None Manufacturing establishments listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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DailyMed publishes the structured product labeling (SPL) that companies submit to the FDA, including package NDCs, ingredients and the establishments that make each product.

Source: U.S. National Library of Medicine (NLM), DailyMed · Source date:

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