Esomeprazole Magnesium Granule, Delayed Release
FDA Label NDC 70771-1391

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Esomeprazole Magnesium (NDC 70771-1391). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Package Label.Principal Display Panel

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC 70771-1391-1

20 mg packet

Rx Only

20 mg Packet (A5b5e9f5 6914 42f0 B51c Fe3a5fead746 01)

20 mg Packet (A5b5e9f5 6914 42f0 B51c Fe3a5fead746 01)

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC 70771-1391-3 unit dose packages of 30: 20 mg packets

Rx Only

20 mg Carton (A5b5e9f5 6914 42f0 B51c Fe3a5fead746 02)

20 mg Carton (A5b5e9f5 6914 42f0 B51c Fe3a5fead746 02)

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC 70771-1392-1

40 mg packet

Rx Only

40 mg Packet (A5b5e9f5 6914 42f0 B51c Fe3a5fead746 03)

40 mg Packet (A5b5e9f5 6914 42f0 B51c Fe3a5fead746 03)

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC 70771-1392-3 unit dose packages of 30: 40 mg packets

Rx Only

40 mg Carton (A5b5e9f5 6914 42f0 B51c Fe3a5fead746 04)

40 mg Carton (A5b5e9f5 6914 42f0 B51c Fe3a5fead746 04)

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