United States · FDA National Drug Code directory

Diphenoxylate Hydrochloride and Atropine Sulfate

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
71610-809_159ed936-248b-38c9-e063-6394a90a0f2a
Product NDC
71610-809
Form
TABLET
Composition / generic term
diphenoxylate hydrochloride and atropine sulfate
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Marketing category
ANDA
Marketing start / end (source format)
20200315
Source listing expiry
20261231

Source-listed ingredients

  • DIPHENOXYLATE HYDROCHLORIDE — 2.5 mg/1
  • ATROPINE SULFATE — .025 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 60 TABLET in 1 BOTTLE (71610-809-53) · 71610-809-53
  • 90 TABLET in 1 BOTTLE (71610-809-60) · 71610-809-60
  • 120 TABLET in 1 BOTTLE (71610-809-70) · 71610-809-70
  • 180 TABLET in 1 BOTTLE (71610-809-80) · 71610-809-80
  • 240 TABLET in 1 BOTTLE (71610-809-90) · 71610-809-90

Source and coverage

Open FDA National Drug Code directory

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.

Browse United States records →