Drugplain

Estradiol Transdermal System .1 mg/d

Estradiol · PATCH · Sandoz Inc

10 Recalls on RecordCurrently in Shortage
Plain English

Estradiol Transdermal System is a patch containing estradiol at .1 mg/d, taken transdermal. Manufactured by Sandoz Inc.

Key Facts

Brand Name
Estradiol Transdermal System
Generic Name
Estradiol
NDC Code (Product)
0781-7104
Manufacturer
Sandoz Inc
Strength
.1 mg/d
Dosage Form
PATCH
Route
TRANSDERMAL
Marketing Status
Application #
NDA020375
Drug Class
Estrogen [EPC]
Marketing Start
12/22/1994

Recall History

10 Recalls on Record
Class II09/07/2018

Noven Pharmaceuticals, Inc.

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

TerminatedVoluntary: Firm initiated
Class II04/16/2021

Noven Pharmaceuticals Inc

Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

TerminatedVoluntary: Firm initiated
Class II09/07/2018

Noven Pharmaceuticals, Inc.

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

TerminatedVoluntary: Firm initiated
Class III05/16/2024

Zydus Pharmaceuticals (USA) Inc

Failed Impurities/Degradation Specifications.

OngoingVoluntary: Firm initiated
Class II05/04/2018

Noven Pharmaceuticals, Inc.

Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

TerminatedVoluntary: Firm initiated
Class II04/16/2021

Noven Pharmaceuticals Inc

Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

TerminatedVoluntary: Firm initiated
Class II09/07/2018

Noven Pharmaceuticals, Inc.

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

TerminatedVoluntary: Firm initiated
Class II05/04/2018

Noven Pharmaceuticals, Inc.

Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

TerminatedVoluntary: Firm initiated
Class III04/27/2017

Noven Pharmaceuticals, Inc.

Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.

TerminatedVoluntary: Firm initiated
Class II09/07/2018

Noven Pharmaceuticals, Inc.

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Estradiol Transdermal System used for?

Estradiol Transdermal System contains Estradiol. It is a patch taken transdermal. Consult your doctor for specific uses.

Is Estradiol Transdermal System a controlled substance?

Estradiol Transdermal System is not classified as a controlled substance by the DEA.

What is the generic name for Estradiol Transdermal System?

The generic name for Estradiol Transdermal System is Estradiol. There are 12 other brand versions of Estradiol.

What is the NDC code for Estradiol Transdermal System .1 mg/d?

The NDC (National Drug Code) for Estradiol Transdermal System .1 mg/d is 0781-7104, listed by Sandoz Inc.