BUPIVACAINE HYDROCHLORIDE (Page 5 of 5)

HOW SUPPLIED

0.5% BUPIVACAINE HYDROCHLORIDE INJECTION, USP is supplied in the following dosage forms.
NDC 51662-1396-1
0.5% BUPIVACAINE HYDROCHLORIDE INJECTION, USP (5 mg/mL) 50 mL MDV

NDC 51662-1396-2
Pouch containing a single 0.5% BUPIVACAINE HYDROCHLORIDE INJECTION, USP (5 mg/mL) 50 mL MDV

NDC 51662-1396-3
Case of 25 pouches — 0.5% BUPIVACAINE HYDROCHLORIDE INJECTION, USP (5 mg/mL) 50 mL MDV

HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275

Also supplied in the following manufacture supplied dosage forms

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.

HOW SUPPLIED 1
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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.

HOW SUPPLIED 2
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For single-dose ampuls and vials: Discard the unused portion.

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

LOGO
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LAB-1176-2.0

Revised: 12/2018

PRINCIPAL DISPLAY PANEL — VIAL LABEL

VIAL LABEL
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PRINCIPAL DISPLAY PANEL — SERIALIZED VIAL LABELING

SERIALIZED VIAL LABELING
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Principal Display Panel — 51662-1396-2 — Pouch Labeling

Pouch Labeling
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Principal Display Panel — 51662-1396-3 — Case Labeling

RFID Labeling
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Case Labeling
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PRINCIPAL DISPLAY PANEL — 51662-1396 POUCH LABELING EFFECTIVE JULY 19, 2021

51662-1396-2 POUCH LABELING EFFECTIVE JULY 19, 2021

POUCH LABELING UPDATED JULY 2021
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BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1396(NDC:0409-1163)
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
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN 1 mg in 1 mL
SODIUM HYDROXIDE
WATER
SODIUM CHLORIDE 8.1 mg in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1396-1 50 mL in 1 VIAL, MULTI-DOSE None
2 NDC:51662-1396-3 25 POUCH in 1 CASE contains a POUCH (51662-1396-2)
2 NDC:51662-1396-2 1 mL in 1 POUCH This package is contained within the CASE (51662-1396-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070597 10/16/2019
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 (51662-1396)

Revised: 07/2021 HF Acquisition Co LLC, DBA HealthFirst

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