Roflumilast Tablet
FDA Label NDC 70771-1674

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 Roflumilast (NDC 70771-1674). 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 70771-1674-3

Roflumilast Tablets, 500 mcg

30 tablets

Rx only

500 Mcg Label (17412ffc 3fe3 4503 A5d4 65f3421da18d 01)

500 Mcg Label (17412ffc 3fe3 4503 A5d4 65f3421da18d 01)

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