Estradiol Patch, Extended Release - FDA Label NDC 70771-1563

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Estradiol (NDC 70771-1563). 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

Package Label – 0.025 mg

NDC 70771-1563-8

Estradiol Transdermal System, USP

(Twice-Weekly)

Delivers 0.025 mg/day

Includes 8 Systems

Rx Only

zydus pharmaceuticals

0.025mg (260eb67a A1fc 4dae 9f69 345ea6ad9f83 01)

Package Label – 0.0375 mg

NDC 70771-1564-8

Estradiol Transdermal System, USP

(Twice-Weekly)

Delivers 0.0375 mg/day

Includes 8 Systems

Rx Only

zydus pharmaceuticals

0.0375mg (260eb67a A1fc 4dae 9f69 345ea6ad9f83 02)

Package Label – 0.05 mg

NDC 70771-1565-8

Estradiol Transdermal System, USP

(Twice-Weekly)

Delivers 0.05 mg/day

Includes 8 Systems

Rx Only

zydus pharmaceuticals

0.05mg (260eb67a A1fc 4dae 9f69 345ea6ad9f83 03)

Package Label – 0.075 mg

NDC 70771-1566-8

Estradiol Transdermal System, USP

(Twice-Weekly)

Delivers 0.075 mg/day

Includes 8 Systems

Rx Only

zydus pharmaceuticals

0.075mg (260eb67a A1fc 4dae 9f69 345ea6ad9f83 04)

Package Label – 0.1 mg

NDC 70771-1567-8

Estradiol Transdermal System, USP

(Twice-Weekly)

Delivers 0.1 mg/day

Includes 8 Systems

Rx Only

zydus pharmaceuticals

0.1mg (260eb67a A1fc 4dae 9f69 345ea6ad9f83 05)

Estradiol Patch, Extended Release
FDA Label NDC 70771-1563

Structured Product Label

Label Section Quick Index

Package Label.Principal Display Panel