Dantrolene
Dantrolene Sodium for Injection, USP Rx only
Approved
Approval ID
ab0efc75-0598-4f4e-91ad-6195bb2661fe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2022
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.
Dantrolene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9297
Application NumberANDA204762
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dantrolene
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 9, 2022
FDA Product Classification
INGREDIENTS (3)
MANNITOLInactive
Quantity: 3000 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DANTROLENE SODIUMActive
Quantity: 20 mg in 1 1
Code: 287M0347EV
Classification: ACTIB