United States · FDA National Drug Code directory

Mesalamine

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: 65162-360_21f01ad5-99ad-49d4-b3d6-2b9470238f22
Product NDC: 65162-360
Form: TABLET, DELAYED RELEASE
Composition / generic term: Mesalamine
Labeler: Amneal Pharmaceuticals LLC
Marketing category: ANDA
Marketing start / end (source format): 20250219
Source listing expiry: 20271231

Source-listed ingredients

MESALAMINE — 800 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

180 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-360-18) · 65162-360-18

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 →