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: 68382-435_a54ad8c8-c4d4-4e52-8cb8-3b7ffde63739
Product NDC: 68382-435
Form: TABLET, DELAYED RELEASE
Composition / generic term: mesalamine
Labeler: Zydus Pharmaceuticals USA Inc.
Marketing category: ANDA
Marketing start / end (source format): 20180802
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 (68382-435-28) · 68382-435-28
10 BLISTER PACK in 1 CARTON (68382-435-77) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68382-435-30) · 68382-435-77

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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