RYANODEX
These highlights do not include all the information needed to use RYANODEX safely and effectively. See full prescribing information for RYANODEX. RYANODEX (dantrolene sodium) for injectable suspension, for intravenous use. Initial U.S. Approval: 1974
Approved
Approval ID
8f7b3ac0-604d-4c78-b545-5e0f8ea3d698
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 7, 2020
Manufacturers
FDA
Eagle Pharmaceuticals, Inc.
DUNS: 849818161
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 Code42367-540
Application NumberNDA205579
Product Classification
M
Marketing Category
C73594
G
Generic Name
dantrolene sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (8)
DANTROLENE SODIUMActive
Quantity: 250 mg in 5 mL
Code: 287M0347EV
Classification: ACTIB
POVIDONE K12Inactive
Code: 333AG72FWJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT