trudhesa

Generic: dihydroergotamine mesylate

Labeler: impel pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name trudhesa
Generic Name dihydroergotamine mesylate
Labeler impel pharmaceuticals llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

dihydroergotamine mesylate 4 mg/mL

Manufacturer
Impel Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 77530-725
Product ID 77530-725_8118afb5-12dc-4dee-91e8-731286b0c1a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213436
Listing Expiration 2026-12-31
Marketing Start 2021-09-24

Pharmacologic Class

Classes
ergotamine derivative [epc] ergotamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 77530725
Hyphenated Format 77530-725

Supplemental Identifiers

RxCUI
2569836 2569842
UNII
81AXN7R2QT

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name trudhesa (source: ndc)
Generic Name dihydroergotamine mesylate (source: ndc)
Application Number NDA213436 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (77530-725-00) / 1 mL in 1 VIAL, GLASS
  • 4 VIAL, GLASS in 1 CARTON (77530-725-04) / 1 mL in 1 VIAL, GLASS
source: ndc

Packages (2)

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

Ingredients (1)

dihydroergotamine mesylate (4 mg/mL)

Linked Drug Pages (1)

Trudhesa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "8118afb5-12dc-4dee-91e8-731286b0c1a8", "openfda": {"unii": ["81AXN7R2QT"], "rxcui": ["2569836", "2569842"], "spl_set_id": ["b81397b0-910d-4eb4-8fee-a9a3c9d94d63"], "manufacturer_name": ["Impel Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 VIAL, GLASS in 1 CARTON (77530-725-00)  / 1 mL in 1 VIAL, GLASS", "package_ndc": "77530-725-00", "marketing_start_date": "20210924"}, {"sample": false, "description": "4 VIAL, GLASS in 1 CARTON (77530-725-04)  / 1 mL in 1 VIAL, GLASS", "package_ndc": "77530-725-04", "marketing_start_date": "20210924"}], "brand_name": "Trudhesa", "product_id": "77530-725_8118afb5-12dc-4dee-91e8-731286b0c1a8", "dosage_form": "SPRAY, METERED", "pharm_class": ["Ergotamine Derivative [EPC]", "Ergotamines [CS]"], "product_ndc": "77530-725", "generic_name": "Dihydroergotamine mesylate", "labeler_name": "Impel Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trudhesa", "active_ingredients": [{"name": "DIHYDROERGOTAMINE MESYLATE", "strength": "4 mg/mL"}], "application_number": "NDA213436", "marketing_category": "NDA", "marketing_start_date": "20210924", "listing_expiration_date": "20261231"}