BUPIVACAINE HCI AND EPINEPHRINE (Page 5 of 5)

SPL UNCLASSIFIED

LOGO
(click image for full-size original)

Lake Zurich, IL 60047

www.fresenius-kabi.com/us

451106H

Revised: March 2019

PRINCIPAL DISPLAY PANEL — VIAL LABEL FULL

VIAL LABEL 2
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — VIAL LABEL FRONT

VIAL FRONT
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — SERIALIZED VIAL LABELING

SWERIALIZED VIAL LABELING
(click image for full-size original)

Principal Display Panel — Pouch Labeling 51662-1399-2

Pouch Labeling
(click image for full-size original)

Principal Display Panel- Case Labeling, 51662-1399-3

Case Labeling
(click image for full-size original)

Case RFID Label
(click image for full-size original)
BUPIVACAINE HCI AND EPINEPHRINE
bupivacaine hci and epinephrine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1399(NDC:63323-463)
Route of Administration PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE 5 mg in 1 mL
EPINEPHRINE BITARTRATE (EPINEPHRINE) EPINEPHRINE 0.005 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 0.2 mg in 1 mL
SODIUM METABISULFITE (BISULFITE ION) 0.5 mg in 1 mL
HYDROCHLORIC ACID
SODIUM CHLORIDE 8 mg in 1 mL
SODIUM HYDROXIDE
METHYLPARABEN 1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1399-1 50 mL in 1 VIAL, MULTI-DOSE None
2 NDC:51662-1399-2 1 VIAL, MULTI-DOSE in 1 POUCH contains a VIAL, MULTI-DOSE
2 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the POUCH (51662-1399-2)
3 NDC:51662-1399-3 25 POUCH in 1 CASE contains a POUCH
3 1 VIAL, MULTI-DOSE in 1 POUCH This package is contained within the CASE (51662-1399-3) and contains a VIAL, MULTI-DOSE
3 50 mL in 1 VIAL, MULTI-DOSE This package is contained within a POUCH and a CASE (51662-1399-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070968 12/09/2019
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1399)

Revised: 01/2021 HF Acquisition Co LLC, DBA HealthFirst

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.