Revonto
Revonto (dantrolene sodium for injection)
Approved
Approval ID
f1650487-32bd-4017-b9c2-b38829a531af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2021
Manufacturers
FDA
USWM, LLC
DUNS: 117542566
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dantrolene sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code78670-003
Application NumberANDA078378
Product Classification
M
Marketing Category
C73584
G
Generic Name
dantrolene sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 7, 2021
FDA Product Classification
INGREDIENTS (3)
dantrolene sodiumActive
Quantity: 20 mg in 60 mL
Code: 287M0347EV
Classification: ACTIB
mannitolInactive
Quantity: 3000 mg in 60 mL
Code: 3OWL53L36A
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT