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ZTALMY

NDC 81583-100, ganaxolone, suspension, from Immedica Pharma US Inc.

Product NDC
81583-100
Status
Listed
Labeler
Immedica Pharma US Inc
Dosage form
SUSPENSION
Route
ORAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
NDA
Application
NDA215904
DEA schedule
CV
Request
curl https://api.healthcare.dev/v1/drugs/ndc/81583-100 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • GANAXOLONE50 mg/mL

Pharmacologic classes

GABA A Receptor Positive Modulators [MoA]; Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]

Package NDCNDC-11Package
81583-100-01815830100011 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/d91612c4-b03a-4be4-a1ee-6a13e3b83d4e

Use it

Look up 81583-100 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/81583-100 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 81583-100. Tell me the product, its labeler, dosage form and route, its packages, and the RxNorm concepts it maps to.
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Source: FDA, release 2026-10-23. Public domain. Reference data, not medical advice.