Estradiol Transdermal System

SPL v1

SPL

SPL Set ID 8b672c79-0896-4d6e-b225-299e89068ad7

Route

TRANSDERMAL

Published

Effective Date 2023-04-21

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Estradiol (0.025 mg)

Inactive Ingredients

2-ethylhexyl Acrylate 2-hydroxyethyl Acrylate Ethyl Oleate Glyceryl Laurate Glycidyl Methacrylate Isopropyl Myristate Povidone Silicon Dioxide Vinyl Acetate

Identifiers & Packaging

Marketing Status

ANDA Active Since 2023-11-02

Description

NDC 70771- 1401 -4 Estradiol Transdermal System, USP 0.025 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1402 -4 Estradiol Transdermal System, USP 0.0375 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1403 -4 Estradiol Transdermal System, USP 0.05 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1404 -4 Estradiol Transdermal System, USP 0.06 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1405 -4 Estradiol Transdermal System, USP 0.075 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1406 -4 Estradiol Transdermal System, USP 0.1 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA

Medication Information

Description

Package Label.principal Display Panel

NDC 70771-1401-4

Estradiol Transdermal System, USP

0.025 mg/day

Continuous Delivery (Once-Weekly)

FOR TRANSDERMAL USE ONLY

Contains 4 transdermal systems

Rx only

zydus Pharmaceuticals USA

NDC 70771-1402-4

Estradiol Transdermal System, USP

0.0375 mg/day

Continuous Delivery (Once-Weekly)

FOR TRANSDERMAL USE ONLY

Contains 4 transdermal systems

Rx only

zydus Pharmaceuticals USA

NDC 70771-1403-4

Estradiol Transdermal System, USP

0.05 mg/day

Continuous Delivery (Once-Weekly)

FOR TRANSDERMAL USE ONLY

Contains 4 transdermal systems

Rx only

zydus Pharmaceuticals USA

NDC 70771-1404-4

Estradiol Transdermal System, USP

0.06 mg/day

Continuous Delivery (Once-Weekly)

FOR TRANSDERMAL USE ONLY

Contains 4 transdermal systems

Rx only

zydus Pharmaceuticals USA

NDC 70771-1405-4

Estradiol Transdermal System, USP

0.075 mg/day

Continuous Delivery (Once-Weekly)

FOR TRANSDERMAL USE ONLY

Contains 4 transdermal systems

Rx only

zydus Pharmaceuticals USA

NDC 70771-1406-4

Estradiol Transdermal System, USP

0.1 mg/day

Continuous Delivery (Once-Weekly)

FOR TRANSDERMAL USE ONLY

Contains 4 transdermal systems

Rx only

zydus Pharmaceuticals USA

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1401-4

Estradiol Transdermal System, USP

0.025 mg/day

Continuous Delivery (Once-Weekly)

FOR TRANSDERMAL USE ONLY

Contains 4 transdermal systems

Rx only

zydus Pharmaceuticals USA

NDC 70771-1402-4

Estradiol Transdermal System, USP

0.0375 mg/day

Continuous Delivery (Once-Weekly)

FOR TRANSDERMAL USE ONLY

Contains 4 transdermal systems

Rx only

zydus Pharmaceuticals USA

NDC 70771-1403-4

Estradiol Transdermal System, USP

0.05 mg/day

Continuous Delivery (Once-Weekly)

FOR TRANSDERMAL USE ONLY

Contains 4 transdermal systems

Rx only

zydus Pharmaceuticals USA

NDC 70771-1404-4

Estradiol Transdermal System, USP

0.06 mg/day

Continuous Delivery (Once-Weekly)

FOR TRANSDERMAL USE ONLY

Contains 4 transdermal systems

Rx only

zydus Pharmaceuticals USA

NDC 70771-1405-4

Estradiol Transdermal System, USP

0.075 mg/day

Continuous Delivery (Once-Weekly)

FOR TRANSDERMAL USE ONLY

Contains 4 transdermal systems

Rx only

zydus Pharmaceuticals USA

NDC 70771-1406-4

Estradiol Transdermal System, USP

0.1 mg/day

Continuous Delivery (Once-Weekly)

FOR TRANSDERMAL USE ONLY

Contains 4 transdermal systems

Rx only

zydus Pharmaceuticals USA

Advanced Ingredient Data

[{"name": "ESTRADIOL", "unii": "4TI98Z838E", "classCode": "ACTIB", "strengthNumerator": "0.025", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "d"}, {"name": "2-ETHYLHEXYL ACRYLATE", "unii": "HR49R9S6XG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "2-HYDROXYETHYL ACRYLATE", "unii": "25GT92NY0C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYL OLEATE", "unii": "Z2Z439864Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL LAURATE", "unii": "Y98611C087", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCIDYL METHACRYLATE", "unii": "R8WN29J8VF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VINYL ACETATE", "unii": "L9MK238N77", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ESTRADIOL", "unii": "4TI98Z838E", "classCode": "ACTIB", "strengthNumerator": "0.0375", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "d"}, {"name": "2-ETHYLHEXYL ACRYLATE", "unii": "HR49R9S6XG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "2-HYDROXYETHYL ACRYLATE", "unii": "25GT92NY0C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYL OLEATE", "unii": "Z2Z439864Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL LAURATE", "unii": "Y98611C087", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCIDYL METHACRYLATE", "unii": "R8WN29J8VF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VINYL ACETATE", "unii": "L9MK238N77", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ESTRADIOL", "unii": "4TI98Z838E", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "d"}, {"name": "2-ETHYLHEXYL ACRYLATE", "unii": "HR49R9S6XG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "2-HYDROXYETHYL ACRYLATE", "unii": "25GT92NY0C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYL OLEATE", "unii": "Z2Z439864Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL LAURATE", "unii": "Y98611C087", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCIDYL METHACRYLATE", "unii": "R8WN29J8VF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VINYL ACETATE", "unii": "L9MK238N77", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ESTRADIOL", "unii": "4TI98Z838E", "classCode": "ACTIB", "strengthNumerator": "0.06", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "d"}, {"name": "2-ETHYLHEXYL ACRYLATE", "unii": "HR49R9S6XG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "2-HYDROXYETHYL ACRYLATE", "unii": "25GT92NY0C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYL OLEATE", "unii": "Z2Z439864Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL LAURATE", "unii": "Y98611C087", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCIDYL METHACRYLATE", "unii": "R8WN29J8VF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VINYL ACETATE", "unii": "L9MK238N77", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ESTRADIOL", "unii": "4TI98Z838E", "classCode": "ACTIB", "strengthNumerator": "0.075", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "d"}, {"name": "2-ETHYLHEXYL ACRYLATE", "unii": "HR49R9S6XG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "2-HYDROXYETHYL ACRYLATE", "unii": "25GT92NY0C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYL OLEATE", "unii": "Z2Z439864Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL LAURATE", "unii": "Y98611C087", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCIDYL METHACRYLATE", "unii": "R8WN29J8VF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VINYL ACETATE", "unii": "L9MK238N77", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ESTRADIOL", "unii": "4TI98Z838E", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "d"}, {"name": "2-ETHYLHEXYL ACRYLATE", "unii": "HR49R9S6XG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "2-HYDROXYETHYL ACRYLATE", "unii": "25GT92NY0C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYL OLEATE", "unii": "Z2Z439864Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL LAURATE", "unii": "Y98611C087", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCIDYL METHACRYLATE", "unii": "R8WN29J8VF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VINYL ACETATE", "unii": "L9MK238N77", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771- 1401 -4 Estradiol Transdermal System, USP 0.025 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1402 -4 Estradiol Transdermal System, USP 0.0375 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1403 -4 Estradiol Transdermal System, USP 0.05 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1404 -4 Estradiol Transdermal System, USP 0.06 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1405 -4 Estradiol Transdermal System, USP 0.075 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1406 -4 Estradiol Transdermal System, USP 0.1 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:39:13.018758 · Updated: 2026-03-14T21:56:58.197015