Drugplain

Norgestimate and Ethinyl Estradiol

Norgestimate and Ethinyl Estradiol · KIT · Glenmark Pharmaceuticals Inc., USA

4 Recalls on Record
Plain English

Norgestimate and ethinyl estradiol is a prescription birth control pill that combines a progestin and an estrogen to prevent pregnancy. It is taken by mouth as directed on the package.

Key Facts

Brand Name
Norgestimate and Ethinyl Estradiol
Generic Name
Norgestimate and Ethinyl Estradiol
NDC Code (Product)
68462-565
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Dosage Form
KIT
Marketing Status
Application #
ANDA200494
Marketing Start
06/17/2011

Recall History

4 Recalls on Record
Class II09/02/2025

AvKARE

Failed Content Uniformity Specifications

OngoingVoluntary: Firm initiated
Class III01/10/2020

Lupin Pharmaceuticals Inc.

CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.

TerminatedVoluntary: Firm initiated
Class II03/07/2024

Teva Pharmaceuticals USA, Inc

Failed Dissolution Specifications

TerminatedVoluntary: Firm initiated
Class II06/21/2013

Sandoz Incorporated

Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Norgestimate and Ethinyl Estradiol used for?

Norgestimate and ethinyl estradiol is a prescription birth control pill that combines a progestin and an estrogen to prevent pregnancy. It is taken by mouth as directed on the package.

Is Norgestimate and Ethinyl Estradiol a controlled substance?

Norgestimate and Ethinyl Estradiol is not classified as a controlled substance by the DEA.

What is the generic name for Norgestimate and Ethinyl Estradiol?

The generic name for Norgestimate and Ethinyl Estradiol is Norgestimate and Ethinyl Estradiol. There are 10 other brand versions of Norgestimate and Ethinyl Estradiol.

What is the NDC code for Norgestimate and Ethinyl Estradiol ?

The NDC (National Drug Code) for Norgestimate and Ethinyl Estradiol is 68462-565, listed by Glenmark Pharmaceuticals Inc., USA.