Dantrium
Dantrium® Intravenous (dantrolene sodium for injection)
Approved
Approval ID
4df35098-8702-46be-ac67-30cfdf1aa570
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2017
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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 Code42023-123
Application NumberNDA018264
Product Classification
M
Marketing Category
C73594
G
Generic Name
dantrolene sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 31, 2017
FDA Product Classification
INGREDIENTS (3)
DANTROLENE SODIUMActive
Quantity: 20 mg in 60 mL
Code: 287M0347EV
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT