United States · FDA National Drug Code directory

Duloxetine

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
80425-0389_25137bab-44cd-121d-e063-6394a90a2717
Product NDC
80425-0389
Form
CAPSULE, DELAYED RELEASE
Composition / generic term
Duloxetine
Labeler
Advanced Rx of Tennessee, LLC
Marketing category
ANDA
Marketing start / end (source format)
20240522
Source listing expiry
20261231

Source-listed ingredients

  • DULOXETINE HYDROCHLORIDE — 60 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0389-1) · 80425-0389-1
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0389-2) · 80425-0389-2
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0389-3) · 80425-0389-3

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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