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
- 85534-0016_5b063723-7f0a-3541-e063-6294a90ad207
- Product NDC
- 85534-0016
- Form
- CAPSULE, DELAYED RELEASE
- Composition / generic term
- Duloxetine
- Labeler
- HAWAII REPACK, INC.
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20170316
- Source listing expiry
- 20271231
Source-listed ingredients
- DULOXETINE HYDROCHLORIDE — 20 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0016-0) · 85534-0016-0
- 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0016-1) · 85534-0016-1
- 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0016-2) · 85534-0016-2
- 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0016-3) · 85534-0016-3
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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