United States · FDA National Drug Code directory

ZTALMY

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
81583-100_44a8cd9a-8b14-93c2-e063-6394a90aef51
Product NDC
81583-100
Form
SUSPENSION
Composition / generic term
ganaxolone
Labeler
Immedica Pharma US Inc
Marketing category
NDA
Marketing start / end (source format)
20220606
Source listing expiry
20261231

Source-listed ingredients

  • GANAXOLONE — 50 mg/mL

These values do not establish equivalence or a dose recommendation.

Packages

  • 1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC · 81583-100-01

Source and coverage

Open FDA National Drug Code directory

Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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