NDC Code(s) : 27505-003-68
Packager : US WorldMeds, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Revontodantrolene sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27505-003
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
dantrolene sodium(UNII: 287M0347EV)
(dantrolene - UNII:F64QU97QCR) 		dantrolene sodium20 mg in 60 mL
Inactive Ingredients
Ingredient Name Strength
mannitol(UNII: 3OWL53L36A)3000 mg in 60 mL
sodium hydroxide(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:27505-003-686 in 1 CARTON
160 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078378 06/04/2012 03/31/2017

PRINCIPAL DISPLAY PANEL

6 Vials Nonreturnable
NDC 27505-003-68
009309

Revonto®
(dantrolene sodium for injection)

20 mg

For treatment of malignant hyperthermia
FOR INTRAVENOUS USE ONLY

Rx Only
NOVAPLUS ®

Principal Display Panel - 20 mg Carton