NDC Code(s) : 24477-312-01, 24477-312-02, 24477-311-01, 24477-311-02
Packager : EKR Therapeutics, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cardene I.V.nicardipine hydrochloride INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24477-312
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICARDIPINE HYDROCHLORIDE(UNII: K5BC5011K3)
(NICARDIPINE - UNII:CZ5312222S) 		NICARDIPINE HYDROCHLORIDE0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)48 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)0.0192 mg in 1 mL
SORBITOL(UNII: 506T60A25R)1.92 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24477-312-0210 in 1 BOX
1NDC:24477-312-011 in 1 CARTON
1200 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019734 01/30/1992

INGREDIENTS AND APPEARANCE

Cardene I.V.nicardipine hydrochloride INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24477-311
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICARDIPINE HYDROCHLORIDE(UNII: K5BC5011K3)
(NICARDIPINE - UNII:CZ5312222S) 		NICARDIPINE HYDROCHLORIDE0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.6 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)0.0192 mg in 1 mL
SORBITOL(UNII: 506T60A25R)1.92 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24477-311-0210 in 1 BOX
1NDC:24477-311-011 in 1 CARTON
1200 mL in 1 BAG
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 - 0.1 mg (Dextrose diluent) Bag

0.1 mg (Dextrose diluent) Bag

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel - 0.1 mg (Dextrose diluent) Carton

0.1 mg (Dextrose diluent) Carton

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel - 0.1 mg (Sodium Chloride diluent) Bag

0.1 mg (Sodium Chloride diluent) Bag

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel - 0.1 mg (Sodium Chloride diluent) Carton

0.1 mg (Sodium Chloride diluent) Carton