NDC Code(s) : 41616-882-40, 41616-882-44
Packager : Sun Pharma Global Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NICARdipine Hydrochloride NICARdipine Hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:41616-882
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)
WATER(UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41616-882-4410 in 1 CARTON
1NDC:41616-882-401 in 1 CARTON
110 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA078405 11/17/2009

PRINCIPAL DISPLAY PANEL

NDC 41616-882-40
NICARdipine Hydrochloride Injection
25 mg/10 mL
(2.5 mg/mL)
For I.V. Infusion
10 mL ampul
Rx only

nicardipine-10mL ampul label

PRINCIPAL DISPLAY PANEL

NDC 41616-882-40
NICARdipine Hydrochloride Injection
25 mg/10 mL
(2.5 mg/mL)
For I.V. Infusion
WARNING: MUST BE DILUTED BEFORE INFUSION
10 mL ampul
Rx only
SUN PHARMACEUTICAL INDUSTRIES LTD.

nicardipine-10mL ampul carton

PRINCIPAL DISPLAY PANEL


NDC 41616-882-44
NICARdipine Hydrochloride Injection
25 mg/10 mL
(2.5 mg/mL)
For I.V. Infusion
WARNING: MUST BE DILUTED BEFORE INFUSION
10 mL
10 ampuls
Rx only
SUN PHARMACEUTICAL INDUSTRIES LTD.

nicardipine-10 ampuls carton