Drugplain

INTROVALE

Levonorgestrel and Ethinyl Estradiol tablets · KIT · Xiromed LLC

1 Recall on Record
Plain English

INTROVALE is a kit containing levonorgestrel and ethinyl estradiol tablets. Manufactured by Xiromed LLC.

Key Facts

Brand Name
INTROVALE
Generic Name
Levonorgestrel and Ethinyl Estradiol tablets
NDC Code (Product)
70700-208
Manufacturer
Xiromed LLC
Dosage Form
KIT
Marketing Status
Application #
ANDA200490
Marketing Start
01/29/2025

Recall History

1 Recall on Record
Class III08/07/2013

Sandoz Incorporated

Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is INTROVALE used for?

INTROVALE contains Levonorgestrel and Ethinyl Estradiol tablets. It is a kit taken as directed. Consult your doctor for specific uses.

Is INTROVALE a controlled substance?

INTROVALE is not classified as a controlled substance by the DEA.

What is the generic name for INTROVALE?

The generic name for INTROVALE is Levonorgestrel and Ethinyl Estradiol tablets. There are no other listed brand versions of Levonorgestrel and Ethinyl Estradiol tablets.

What is the NDC code for INTROVALE ?

The NDC (National Drug Code) for INTROVALE is 70700-208, listed by Xiromed LLC.

Product NDC

70700-208

Package NDC

70700-208-88

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)