NESACAINE (Page 4 of 4)

HOW SUPPLIED:

NESACAINE® (chloroprocaine HCL Injection, USP) with preservatives is supplied as follows:

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NESACAINE®-MPF (chloroprocaine HCL Injection, USP) without preservatives and without EDTA is supplied as follows:

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For single-dose vials: Discard unused portion.

Keep from freezing. Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

All trademarks are the property of Fresenius Kabi USA, LLC.

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SAMPLE PACKAGE LABEL

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NESACAINE
chloroprocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-476(NDC:63323-476)
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROPROCAINE HYDROCHLORIDE (CHLOROPROCAINE) CHLOROPROCAINE HYDROCHLORIDE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 4.7 mg in 1 mL
EDETATE DISODIUM 0.111 mg in 1 mL
METHYLPARABEN 1 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-476-37 1 VIAL, MULTI-DOSE in 1 BAG contains a VIAL, MULTI-DOSE
1 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the BAG (52584-476-37)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA009435 01/30/2013
Labeler — General Injectables & Vaccines, Inc (108250663)

Revised: 11/2021 General Injectables & Vaccines, Inc

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