NAROPIN (Page 5 of 5)

Sample Package Label

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NAROPIN ropivacaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-286(NDC:63323-286)
Route of Administration INFILTRATION, PERINEURAL, EPIDURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE) ROPIVACAINE HYDROCHLORIDE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-286-35 1 VIAL, SINGLE-DOSE in 1 BAG contains a VIAL, SINGLE-DOSE
1 30 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BAG (52584-286-35)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020533 03/11/2014 09/30/2025
Labeler — General Injectables & Vaccines, Inc (108250663)

Revised: 12/2022 General Injectables & Vaccines, Inc

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