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United States · US · US:77530-725_8118afb5-12dc-4dee-91e8-731286b0c1a8

Trudhesa

Orange BookUNIISPLATC N02CA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerImpel Pharmaceuticals LLC
CountryUS (United States)
ATC codeN02CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7753072500
    1 VIAL, GLASS in 1 CARTON (77530-725-00) / 1 mL in 1 VIAL, GLASS
  • ndc11
    7753072504
    4 VIAL, GLASS in 1 CARTON (77530-725-04) / 1 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
81AXN7R2QT
DIHYDROERGOTAMINE MESYLATE
RxCUI 203176
Orange Book
N213436
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "81AXN7R2QT",
    "rxcui": "203176",
    "inchikey": "ADYPXRFPBQGGAH-UMYZUSPBSA-N",
    "display_name": "DIHYDROERGOTAMINE MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "b81397b0-910d-4eb4-8fee-a9a3c9d94d63": {
      "match": "brand_token",
      "title": "TRUDHESA (DIHYDROERGOTAMINE MESYLATE) SPRAY, METERED [IMPEL PHARMACEUTICALS LLC]",
      "spl_version": "6",
      "published_date": "2025-01-27"
    }
  },
  "productid": "77530-725_8118afb5-12dc-4dee-91e8-731286b0c1a8",
  "productndc": "77530-725",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "213436",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.725MG/SPRAY",
        "product_no": "001",
        "approval_date": "Sep 2, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIHYDROERGOTAMINE MESYLATE",
  "proprietary_name": "Trudhesa",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA213436",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dihydroergotamine mesylate",
  "start_marketing_date": "20210924",
  "active_numerator_strength": "4"
}

Related drugs

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