Dihydroergotamine Mesylate
The solution used in Dihydroergotamine Mesylate Nasal Spray (4 mg/mL) is intended for intranasal use and must not be injected.Rx Only
Approved
Approval ID
9ffe6d5a-7348-0498-e053-2a95a90a97a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 24, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 118707839
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 Code24201-463
Application NumberANDA211393
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dihydroergotamine Mesylate
Product Specifications
Route of AdministrationNASAL
Effective DateApril 24, 2023
FDA Product Classification
INGREDIENTS (5)
CAFFEINEInactive
Code: 3G6A5W338E
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIHYDROERGOTAMINE MESYLATEActive
Quantity: 4 mg in 1 mL
Code: 81AXN7R2QT
Classification: ACTIB