Mesalamine

FDA NDC Directory

Ingredient names as written by FDA

MESALAMINE

Dosage forms

Capsule, Capsule, Delayed Release, Capsule, Extended Release, Enema, Suppository, Suspension, Tablet, Delayed Release

Routes

Oral, Rectal

Manufacturers / labelers

39

Strengths listed

.375 g/1 · 1.2 g/1 · 1000 mg/1 · 250 mg/1 · 375 mg/1 · 4 g/60ml · 400 mg/1 · 500 mg/1 · 800 mg/1

Brand names in FDA listings

Apriso, Canasa, Lialda, Mesalamine Rectal, Pentasa, Rowasa

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 52582

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

Official labeling on DailyMed

• MESALAMINE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] · version 6 · 2026-09-14
• APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.] · version 35 · 2026-08-31
• ROWASA (MESALAMINE) SUSPENSION [VIATRIS SPECIALTY LLC] · version 18 · 2026-08-07
• MESALAMINE TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS] · version 8 · 2026-08-07
• MESALAMINE CAPSULE, EXTENDED RELEASE [SANDOZ INC] · version 3 · 2026-07-30
• MESALAMINE TABLET, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] · version 9 · 2026-07-16
• MESALAMINE TABLET, DELAYED RELEASE [NUVAILA LIMITED] · version 1 · 2026-07-01
• MESALAMINE SUSPENSION [ANI PHARMACEUTICALS, INC.] · version 3 · 2026-05-21
• MESALAMINE TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC] · version 10 · 2026-05-04
• MESALAMINE SUSPENSION [KLM LABORATORIES PRIVATE LIMITED] · version 5 · 2026-04-03
• LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.] · version 49 · 2026-03-26
• MESALAMINE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 1 · 2026-03-09

Showing the 12 most recent of 60 labels.