Home SPL Set DailyMed Esomeprazole Magnesium For Delayed-release Oral Suspension Esomeprazole Magnesium For Delayed-release Oral Suspension SPL v2 SPL SPL Set ID 4cd9e802-c519-4593-bc38-947ad7f9b567 Route ORAL Published Effective Date 2023-06-19 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Esomeprazole (20 mg) Inactive Ingredients Anhydrous Citric Acid Crospovidone Dextrose Ferric Oxide Red Glyceryl Monostearate Hydroxypropyl Cellulose (90000 Wamw) Magnesium Stearate Mannitol Methacrylic Acid And Ethyl Acrylate Copolymer Polysorbate 80 Povidone Strawberry Sucrose Talc Triethyl Citrate Xanthan Gum Hydroxypropyl Cellulose (type E) Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Identifiers & Packaging Pill Appearance Color: brown Color: red Marketing Status ANDA Active Since 2023-06-30 Description Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1391-1 20 mg packet Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1391-3 unit dose packages of 30: 20 mg packets Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1392-1 40 mg packet Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1392-3 unit dose packages of 30: 40 mg packets Rx Only Medication Information Description Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1391-1 20 mg packet Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1391-3 unit dose packages of 30: 20 mg packets Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1392-1 40 mg packet Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1392-3 unit dose packages of 30: 40 mg packets Rx Only Package Label.principal Display Panel Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1391-1 20 mg packet Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1391-3 unit dose packages of 30: 20 mg packets Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1392-1 40 mg packet Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1392-3 unit dose packages of 30: 40 mg packets Rx Only Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1391-1 20 mg packet Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1391-3 unit dose packages of 30: 20 mg packets Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1392-1 40 mg packet Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1392-3 unit dose packages of 30: 40 mg packets Rx Only Advanced Ingredient Data [{"name": "ESOMEPRAZOLE", "unii": "N3PA6559FT", "classCode": "ACTIM", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE (90000 WAMW)", "unii": "UKE75GEA7F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER", "unii": "NX76LV5T8J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STRAWBERRY", "unii": "4J2TY8Y81V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "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": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ESOMEPRAZOLE", "unii": "N3PA6559FT", "classCode": "ACTIM", "strengthNumerator": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE (TYPE E)", "unii": "66O7AQV0RT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A", "unii": "NX76LV5T8J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STRAWBERRY", "unii": "4J2TY8Y81V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "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": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1391-1 20 mg packet Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1391-3 unit dose packages of 30: 20 mg packets Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1392-1 40 mg packet Rx Only Esomeprazole Magnesium For Delayed-Release Oral Suspension NDC 70771-1392-3 unit dose packages of 30: 40 mg packets Rx Only"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:43:58.959538 · Updated: 2026-03-14T22:18:18.443233
