Prescription Drug Information: Bupivacaine Hydrochloride (Page 4 of 4)

HOW SUPPLIED

These solutions are not for spinal anesthesia.

Store at 20 to 25°C (68 to 77°F). excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

Bupivacaine Hydrochloride — Solutions of Bupivacaine Hydrochloride that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes.

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Bupivacaine Hydrochloride with epinephrine 1:200,000 (as bitartrate) #Solutions of Bupivacaine Hydrochloride that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

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For single-dose ampuls and vials: Discard the unused portion.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB- 1176-2.0

Revised: 12/2018

PAA125071

Sample Package Label

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BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-160(NDC:0409-1160)
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bupivacaine Hydrochloride (Bupivacaine) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 2.5 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-160-01 1 VIAL, MULTI-DOSE in 1 BAG contains a VIAL, MULTI-DOSE
1 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the BAG (52584-160-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070590 07/01/2010
Labeler — General Injectables & Vaccines, Inc (108250663)

Revised: 06/2021 General Injectables & Vaccines, Inc

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