04073681-a834-4f45-91c5-224b608b30e6

SPL v3

SPL

SPL Set ID 04073681-a834-4f45-91c5-224b608b30e6

Route

oral

Published

Effective Date 2022-10-31

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

mesalamine (0.375 g)

Inactive Ingredients

ethylcellulose (10 mpa.s) hypromellose 2910 (5 mpa.s) methacrylic acid - methyl methacrylate copolymer (1:1) talc triethyl citrate fd&c blue no. 1 gelatin water sodium lauryl sulfate titanium dioxide ferrosoferric oxide potassium hydroxide propylene glycol shellac sucrose starch, corn

Identifiers & Packaging

Pill Appearance

Imprint: 452 Shape: capsule Color: blue Size: 24 mm Score: 1

Marketing Status

anda active Since 2021-08-13

Description

Mesalamine Extended-Release Capsules, 0.375 g 120 capsules NDC 70771-1625-7 Rx only

Medication Information

Description

Mesalamine Extended-Release Capsules, 0.375 g 120 capsules NDC 70771-1625-7 Rx only

Package Label.principal Display Panel

Mesalamine Extended-Release Capsules, 0.375 g

120 capsules

NDC 70771-1625-7

Rx only

Structured Label Content

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

Mesalamine Extended-Release Capsules, 0.375 g

120 capsules

NDC 70771-1625-7

Rx only

Advanced Ingredient Data

[{"name": "MESALAMINE", "unii": "4Q81I59GXC", "classCode": "ACTIB", "strengthNumerator": "0.375", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "ETHYLCELLULOSE (10 MPA.S)", "unii": "3DYK7UYZ62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (5 MPA.S)", "unii": "R75537T0T4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)", "unii": "74G4R6TH13", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHYL CITRATE", "unii": "8Z96QXD6UM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM HYDROXIDE", "unii": "WZH3C48M4T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "Mesalamine Extended-Release Capsules, 0.375 g 120 capsules NDC 70771-1625-7 Rx only"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:43:59.184046 · Updated: 2026-03-14T22:18:18.443233