Mesalamine Delayed-release Tablets

SPL v7

SPL

SPL Set ID 29c0dd58-d2cf-40fa-bc32-0eab61937331

Route

ORAL

Published

Effective Date 2022-10-21

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Mesalamine (1.2 g)

Inactive Ingredients

Carboxymethylcellulose Sodium Cellulose, Microcrystalline Ferric Oxide Red Ferric Oxide Yellow Hypromelloses Magnesium Stearate Methacrylic Acid Polyethylene Glycol, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance

Imprint: 711 Shape: oval Color: red Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2017-06-19

Description

NDC 70771-1071-1 Mesalamine Delayed-release Tablets, 1.2 g Rx only 120 tablets

Medication Information

Description

NDC 70771-1071-1 Mesalamine Delayed-release Tablets, 1.2 g Rx only 120 tablets

Package Label.principal Display Panel

NDC 70771-1071-1

Mesalamine Delayed-release Tablets, 1.2 g

Rx only

120 tablets

Structured Label Content

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

NDC 70771-1071-1

Mesalamine Delayed-release Tablets, 1.2 g

Rx only

120 tablets

Advanced Ingredient Data

[{"name": "MESALAMINE", "unii": "4Q81I59GXC", "classCode": "ACTIB", "strengthNumerator": "1.2", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHACRYLIC ACID", "unii": "1CS02G8656", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHYL CITRATE", "unii": "8Z96QXD6UM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1071-1 Mesalamine Delayed-release Tablets, 1.2 g Rx only 120 tablets"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:43:59.388220 · Updated: 2026-03-14T22:18:26.158923