NDC Code(s) : 24477-030-10, 24477-030-25
Packager : EKR Therapeutics

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cardene I.V.nicardipine hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24477-030
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICARDIPINE HYDROCHLORIDE(UNII: K5BC5011K3)
(NICARDIPINE - UNII:CZ5312222S) 		NICARDIPINE HYDROCHLORIDE2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SORBITOL(UNII: 506T60A25R)48 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)0.525 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)0.09 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24477-030-101 in 1 BOX
110 mL in 1 AMPULE
2NDC:24477-030-2520 in 1 CASE
210 in 1 BOX
210 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019734 01/30/1992

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel – Vial label

Cardene IV- EKR Vial label

PRINCIPAL DISPLAY PANEL

Container Label - Principal Display Panel – Vial's single box label

Cardene IV- EKR Vial

PRINCIPAL DISPLAY PANEL

Container Label - Principal Display Panel – 10pck carton label

Cardene IV- EKR 10pck carton label

PRINCIPAL DISPLAY PANEL

Container Label - Principal Display Panel – 20crtn Case label

Cardene IV- EKR 20crtn Case label