NDC 62559-0420-07

Mesalamine 4 g/60mL ENEMA

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NDC

62559-0420-07

Generic Name

Mesalamine

Brand Name

Mesalamine

Strength

4 g/60mL

Dosage Form

ENEMA

Route

RECTAL

Package Size

—

Labeler

ANI Pharmaceuticals, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Mesalamine Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.

Important Warnings

WARNINGS Hypersensitivity Reactions Sulfite-Related Reactions Mesalamine Rectal Suspension Enema contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but probably low. S…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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Other Mesalamine NDC Codes

54092-0100-011.2 g/1TABLET, DELAYED RELEASE

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