Drugplain

ZTALMY 50 mg/mL

ganaxolone · SUSPENSION · Immedica Pharma US Inc

No Recall History
Plain English

ZTALMY is a suspension containing ganaxolone at 50 mg/mL, taken oral. Manufactured by Immedica Pharma US Inc.

Key Facts

Brand Name
ZTALMY
Generic Name
ganaxolone
NDC Code (Product)
81583-100
Manufacturer
Immedica Pharma US Inc
Strength
50 mg/mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
DEA Schedule
Schedule V (Controlled)
Application #
NDA215904
Drug Class
Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
Marketing Start
06/06/2022

Recall History

No Recall History

Frequently Asked Questions

What is ZTALMY used for?

ZTALMY contains ganaxolone. It is a suspension taken oral. Consult your doctor for specific uses.

Is ZTALMY a controlled substance?

Yes, ZTALMY is classified as CV under the DEA Controlled Substances Act.

What is the generic name for ZTALMY?

The generic name for ZTALMY is ganaxolone. There are no other listed brand versions of ganaxolone.

What is the NDC code for ZTALMY 50 mg/mL?

The NDC (National Drug Code) for ZTALMY 50 mg/mL is 81583-100, listed by Immedica Pharma US Inc.

Product NDC

81583-100

Package NDC

81583-100-01

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

Data from openFDA · Public domain (CC0 1.0)