5% DEXTROSE (Page 2 of 2)

HOW SUPPLIED

5% DEXTROSE INJECTION, USP is supplied in the following dosage forms.
NDC 51662-1413-1
5% DEXTROSE INJECTION, USP 50mL BAG (QUAD PACK)

HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275

Also supplied in the following manufacture supplied dosage forms

Dextrose Injection, USP is supplied in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying Table.

HOW SUPPLIED
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Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Revised: June, 2010

Printed in USA EN-2531

LOGO
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Hospira, Inc., Lake Forest, IL 60045 USA

PRINCIPAL DISPLAY PANEL — BAG LABELING

BAG LABELING
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PRINCIPAL DISPLAY PANEL — SEERIALIZED LABELING

SERIALIZED LABELING
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5% DEXTROSE 5% dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1413(NDC:0409-7923)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1413-1 50 mL in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016367 10/14/2019
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 (51662-1413)

Revised: 02/2020 HF Acquisition Co LLC, DBA HealthFirst

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