Drugplain

ALTAVERA

Levonorgestrel and Ethinyl Estradiol · KIT · Bryant Ranch Prepack

1 Recall on Record
Plain English

ALTAVERA is a kit containing levonorgestrel and ethinyl estradiol. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
ALTAVERA
Generic Name
Levonorgestrel and Ethinyl Estradiol
NDC Code (Product)
63629-2343
Manufacturer
Bryant Ranch Prepack
Dosage Form
KIT
Marketing Status
Application #
ANDA079102
Marketing Start
01/01/2018

Recall History

1 Recall on Record
Class III09/18/2018

Xiromed LLC

Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea51 reports
headache44 reports
drug ineffective36 reports
fatigue36 reports
vomiting36 reports
dizziness32 reports
anxiety28 reports
dyspnoea28 reports
pulmonary embolism26 reports
diarrhoea24 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Altavera is indicated for use by females of reproductive potential to prevent pregnancy.

Frequently Asked Questions

What is ALTAVERA used for?

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

Is ALTAVERA a controlled substance?

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

What is the generic name for ALTAVERA?

The generic name for ALTAVERA is Levonorgestrel and Ethinyl Estradiol. There are 12 other brand versions of Levonorgestrel and Ethinyl Estradiol.

What is the NDC code for ALTAVERA ?

The NDC (National Drug Code) for ALTAVERA is 63629-2343, listed by Bryant Ranch Prepack.