Dihydroergotamine mesylate
Dihydroergotamine mesylate Nasal Spray The solution used in dihydroergotamine mesylate nasal spray (4 mg/mL) is intended for intranasal use and must not be injected.
Approved
Approval ID
65f8c60d-9213-48ac-8233-acc5d44548f4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 5, 2023
Manufacturers
FDA
Advagen Pharma Ltd
DUNS: 051627256
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dihydroergotamine mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72888-096
Application NumberANDA216881
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dihydroergotamine mesylate
Product Specifications
Route of AdministrationNASAL
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
DIHYDROERGOTAMINE MESYLATEActive
Quantity: 4 mg in 1 mL
Code: 81AXN7R2QT
Classification: ACTIB
CAFFEINEInactive
Code: 3G6A5W338E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT