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United States · US · US:81583-100_44a8cd9a-8b14-93c2-e063-6394a90aef51
ZTALMY
Orange BookUNIISPLATC N03AX27
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerImmedica Pharma US Inc
CountryUS (United States)
ATC codeN03AX27
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1181583100011 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
98WI44OHIQ
GANAXOLONE
RxCUI 2604689
Orange Book
N215904
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "98WI44OHIQ",
"rxcui": "2604689",
"inchikey": "PGTVWKLGGCQMBR-FLBATMFCSA-N",
"display_name": "GANAXOLONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d91612c4-b03a-4be4-a1ee-6a13e3b83d4e": {
"match": "brand_token",
"title": "ZTALMY (GANAXOLONE) SUSPENSION [IMMEDICA PHARMA US INC]",
"spl_version": "13",
"published_date": "2025-12-01"
}
},
"productid": "81583-100_44a8cd9a-8b14-93c2-e063-6394a90aef51",
"productndc": "81583-100",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "215904",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Jun 1, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GANAXOLONE",
"proprietary_name": "ZTALMY",
"active_ingred_unit": "mg/mL",
"application_number": "NDA215904",
"marketing_category": "NDA",
"nonproprietary_name": "ganaxolone",
"start_marketing_date": "20220606",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AX27.
- PLZtalmyMarinus Pharmaceuticals Emerald Limited
- ISZtalmyImmedica Pharma AB
- CZZTALMYImmedica Pharma AB, Stockholm
- CZZTALMYImmedica Pharma AB, Stockholm
- DKZTALMYImmedica Pharma AB
- FIZTALMYImmedica Pharma AB
- BEZtalmy 50 mg/mlMarinus Pharmaceuticals Emerald
- IEZTALMY 50 mg/mL oral suspensionMarinus Pharmaceuticals Emerald Limited
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