Omeprazole Capsule, Delayed Release
FDA Label NDC 65841-761

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 Omeprazole (NDC 65841-761). 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.

Package Label.Principal Display Panel

NDC 65841-759-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 10 mg

Rx only

100 Capsules

Omeprazole Dr Capsules, 10 mg (Daa7fe33 A5c5 48be Bb4d 38cea9e34f33 02)

Omeprazole Dr Capsules, 10 mg (Daa7fe33 A5c5 48be Bb4d 38cea9e34f33 02)

NDC 65841-760-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 20 mg

Rx only

100 Capsules

Omeprazole Dr Capsules, 20 mg (Daa7fe33 A5c5 48be Bb4d 38cea9e34f33 03)

Omeprazole Dr Capsules, 20 mg (Daa7fe33 A5c5 48be Bb4d 38cea9e34f33 03)

NDC 65841-761-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 40 mg

Rx only

100 Capsules

Omeprazole Dr Capsules, 40 mg (Daa7fe33 A5c5 48be Bb4d 38cea9e34f33 04)

Omeprazole Dr Capsules, 40 mg (Daa7fe33 A5c5 48be Bb4d 38cea9e34f33 04)

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