Nicardipine Hydrochloride (Page 5 of 5)

SERIALIZATION IMAGE

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NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9542
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICARDIPINE HYDROCHLORIDE (NICARDIPINE) NICARDIPINE HYDROCHLORIDE 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 7.5 mg in 1 mL
SODIUM HYDROXIDE
2,4-DIHYDROXYBENZOIC ACID .305 mg in 1 mL
Product Characteristics
Color yellow (light yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9542-10 10 VIAL in 1 CARTON contains a VIAL (0143-9542-01)
1 NDC:0143-9542-01 10 mL in 1 VIAL This package is contained within the CARTON (0143-9542-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022276 03/02/2012
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)
Registrant — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 07/2021 Hikma Pharmaceuticals USA Inc.

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