Dihydroergotamine Mesylate
Dihydroergotamine Mesylate Injection, USP
Approved
Approval ID
40b9ba9e-436e-444e-b078-01b12bb57ea7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Provepharm Inc.
DUNS: 086861066
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 Code81284-411
Application NumberANDA212046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dihydroergotamine Mesylate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateAugust 24, 2021
FDA Product Classification
INGREDIENTS (6)
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Dihydroergotamine MesylateActive
Quantity: 1 mg in 1 mL
Code: 81AXN7R2QT
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Methanesulfonic AcidInactive
Code: 12EH9M7279
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT