Darunavir Tablet, Film Coated
FDA Label NDC 70771-1746

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 Darunavir (NDC 70771-1746). 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

NDC 70771-1745-6

Darunavir tablets, 600 mg

60 Tablets

Rx only

Darunavir 600 mg (1b288e91 Dedb 465d 8c45 Eb464dc72e89 01)

Darunavir 600 mg (1b288e91 Dedb 465d 8c45 Eb464dc72e89 01)

NDC 70771-1746-3

Darunavir tablets, 800 mg

30 Tablets

Rx only

Darunavir 800 mg (1b288e91 Dedb 465d 8c45 Eb464dc72e89 02)

Darunavir 800 mg (1b288e91 Dedb 465d 8c45 Eb464dc72e89 02)

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