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
- 43353-594_ef69e563-7239-4c78-8fb4-3cd641fbff17
- Product NDC
- 43353-594
- Form
- TABLET
- Composition / generic term
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20170620
- 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
- 30 TABLET in 1 BOTTLE (43353-594-30) · 43353-594-30
- 60 TABLET in 1 BOTTLE (43353-594-53) · 43353-594-53
- 90 TABLET in 1 BOTTLE (43353-594-60) · 43353-594-60
- 120 TABLET in 1 BOTTLE (43353-594-70) · 43353-594-70
- 180 TABLET in 1 BOTTLE (43353-594-80) · 43353-594-80
- 240 TABLET in 1 BOTTLE (43353-594-90) · 43353-594-90
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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