Esomeprazole Magnesium Delayed-release Capsules

SPL v6

SPL

SPL Set ID 6f314f5d-453c-4876-b9b8-20663008dfb1

Route

ORAL

Published

Effective Date 2023-09-21

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Esomeprazole (20 mg)

Inactive Ingredients

Alcohol Ammonia Butyl Alcohol Fd&c Blue No. 1 Fd&c Red No. 3 Ferrosoferric Oxide Gelatin Glyceryl Mono- And Dicaprylocaprate Hydroxypropyl Cellulose (90000 Wamw) Isopropyl Alcohol Magnesium Oxide Magnesium Stearate Mannitol Methacrylic Acid Polysorbate 80 Potassium Hydroxide Povidone K30 Propylene Glycol Shellac Sodium Lauryl Sulfate Starch, Corn Sucrose Talc Titanium Dioxide Triethyl Citrate Water D&c Red No. 28

Identifiers & Packaging

Pill Appearance

Imprint: 442;40mg Shape: capsule Color: blue Color: white Size: 14 mm Size: 18 mm Score: 1

Marketing Status

ANDA Active Since 2019-05-30

Description

NDC 70771-1493-3 Esomeprazole Magnesium Delayed-release Capsules, USP 20 mg 30 Capsules NDC 70771-1494-3 Esomeprazole Magnesium Delayed-release Capsules, USP 40 mg 30 Capsules

Medication Information

Description

NDC 70771-1493-3 Esomeprazole Magnesium Delayed-release Capsules, USP 20 mg 30 Capsules NDC 70771-1494-3 Esomeprazole Magnesium Delayed-release Capsules, USP 40 mg 30 Capsules

Package Label.principal Display Panel

NDC 70771-1493-3

Esomeprazole Magnesium Delayed-release Capsules, USP

20 mg

30 Capsules

NDC 70771-1494-3

Esomeprazole Magnesium Delayed-release Capsules, USP

40 mg

30 Capsules

Structured Label Content

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

NDC 70771-1493-3

Esomeprazole Magnesium Delayed-release Capsules, USP

20 mg

30 Capsules

NDC 70771-1494-3

Esomeprazole Magnesium Delayed-release Capsules, USP

40 mg

30 Capsules

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1493-3 Esomeprazole Magnesium Delayed-release Capsules, USP 20 mg 30 Capsules NDC 70771-1494-3 Esomeprazole Magnesium Delayed-release Capsules, USP 40 mg 30 Capsules"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:43:58.962269 · Updated: 2026-03-14T22:18:18.443233