Dihydroergotamine Mesylate
DIHYDROERGOTAMINE MESYLATE INJECTION, USP Rx only
Approved
Approval ID
683ca944-efa7-4ca3-9cbe-cf0e7ffb1d64
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 17, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
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 Code0143-9151
Application NumberANDA040453
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dihydroergotamine Mesylate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateMarch 17, 2023
FDA Product Classification
INGREDIENTS (6)
DIHYDROERGOTAMINE MESYLATEActive
Quantity: 1 mg in 1 mL
Code: 81AXN7R2QT
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METHANESULFONIC ACIDInactive
Code: 12EH9M7279
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT