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
NDC Product Code24201-463
Application NumberANDA211393
Marketing CategoryC73584
Route of AdministrationNASAL
Effective DateApril 24, 2023
Generic NameDihydroergotamine Mesylate
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