Mesalamine Suppositories

SPL v7

SPL

SPL Set ID aa63b4bb-2de7-40aa-b26b-1b00b0183eac

Route

RECTAL

Published

Effective Date 2025-01-09

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Mesalamine (1000 mg)

Inactive Ingredients

Fat, Hard

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

ANDA Active Since 2020-02-14

Description

NDC 70771-1513-6 Mesalamine suppositories, 1000 mg 30 rectal suppositories Rx only Image

Medication Information

Description

NDC 70771-1513-6 Mesalamine suppositories, 1000 mg 30 rectal suppositories Rx only Image

Package Label.principal Display Panel

NDC 70771-1513-6

Mesalamine suppositories, 1000 mg

30 rectal suppositories

Rx only

Image

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1513-6

Mesalamine suppositories, 1000 mg

30 rectal suppositories

Rx only

Image

Advanced Ingredient Data

[{"name": "MESALAMINE", "unii": "4Q81I59GXC", "classCode": "ACTIB", "strengthNumerator": "1000", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FAT, HARD", "unii": "8334LX7S21", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1513-6 Mesalamine suppositories, 1000 mg 30 rectal suppositories Rx only Image"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:44:48.915053 · Updated: 2026-03-14T22:21:18.216871