Home SPL Set DailyMed 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
