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United States · US · US:83468-070_6a4934f2-7bae-4f50-9ccc-619d7efe31e1
Cardamyst
Orange BookUNIISPLATC C08DA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMilestone Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeC08DA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183468070032 CONTAINER in 1 CARTON (83468-070-03) / 2 VIAL, SINGLE-DOSE in 1 CONTAINER (83468-070-02) / .2 mL in 1 VIAL, SINGLE-DOSE (83468-070-01)
Annotations
UNII (FDA Substance ID)
S82A18Y42P
ETRIPAMIL
Orange Book
N218571
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "S82A18Y42P",
"rxcui": null,
"inchikey": "VAZNEHLGJGSQEL-MHZLTWQESA-N",
"display_name": "ETRIPAMIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "NASAL",
"spl_meta": {
"a92170b9-4f93-4b83-b2cd-cb85c52821cd": {
"match": "brand_token",
"title": "CARDAMYST (ETRIPAMIL) SPRAY [MILESTONE PHARMACEUTICALS USA, INC.]",
"spl_version": "1",
"published_date": "2026-01-06"
}
},
"productid": "83468-070_6a4934f2-7bae-4f50-9ccc-619d7efe31e1",
"productndc": "83468-070",
"dosage_form": "SPRAY",
"orange_book": {
"appl_no": "218571",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "70MG",
"product_no": "001",
"approval_date": "Dec 12, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETRIPAMIL",
"proprietary_name": "Cardamyst",
"active_ingred_unit": "mg/.2mL",
"application_number": "NDA218571",
"marketing_category": "NDA",
"nonproprietary_name": "etripamil",
"start_marketing_date": "20260105",
"active_numerator_strength": "70"
}Access this data programmatically
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