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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

  • ndc11
    8346807003
    2 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"
}

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