Erlotinib Tablet, Film Coated
FDA Label NDC 70771-1521

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 Erlotinib (NDC 70771-1521). 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

Erlotinib Tablets, 25 mg

30 tablets

NDC 70771-1521-3

Rx only

25 mg Label (5624fa69 Eae5 43bf Aa7e 379266edd77f 01)

25 mg Label (5624fa69 Eae5 43bf Aa7e 379266edd77f 01)

Erlotinib Tablets, 100 mg

30 tablets

NDC 70771-1522-3

Rx only

100 mg Label (5624fa69 Eae5 43bf Aa7e 379266edd77f 02)

100 mg Label (5624fa69 Eae5 43bf Aa7e 379266edd77f 02)

Erlotinib Tablets, 150 mg

30 tablets

NDC 70771-1523-3

Rx only

150 mg Label (5624fa69 Eae5 43bf Aa7e 379266edd77f 03)

150 mg Label (5624fa69 Eae5 43bf Aa7e 379266edd77f 03)

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