Glucose 5% Intravenous Infusion in VIAFLEX Container

Glucose by

Drug Labeling and Warnings

Glucose by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter Healthcare Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GLUCOSE- dextrose monohydrate injection 
Baxter Healthcare Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Glucose 5% Intravenous Infusion
in VIAFLEX Container

Health Care Provider Letter

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Baxter Logo
AHB0086A

Baxter and Viaflex are Registered Trademarks of
Baxter International Inc Baxter Healthcare Pty Ltd
1 Baxter Drive Old Toongabbie NSW Australia

VIAFLEX 88-25-01-068E Store below 30ºC Do Not Freeze
Sterile NonPyrogenic AUST R 19503

AUSTRALIAN MADE Symbol

Use as directed by a physician
Use in one patient on one occasion only
Contains no antimicrobial preservative

Each 50 mL contains
- Anhydrous Glucose 2.5 g
- Water for Injections QS
pH Range 3.5 – 6.5

Approx Millimoles per 50 mL
- Glucose 14
Approx Kilojoules per 50 mL 42 kJ
Approx Osmolality 278 mOsm/kg

ISOTONIC

50 mL Intravenous Infusion

Glucose 5%

F

Bar Code
0 085412 311388

_
25

Baxter Logo
AHB0087

Baxter and Viaflex are Registered Trademarks of
Baxter International Inc Baxter Healthcare Pty Ltd
1 Baxter Drive Old Toongabbie NSW Australia

VIAFLEX 88-25-01-069F Store below 30ºC Do Not Freeze
Sterile NonPyrogenic AUST R 48525

AUSTRALIAN MADE Symbol

Use as directed by a physician
Use in one patient on one occasion only
Contains no antimicrobial preservative

Each 100 mL contains
- Anhydrous Glucose 5 g
- Water for Injections QS
pH Range 3.5 – 6.5

Approx Millimoles per 100 mL
- Glucose 28
Approx Kilojoules per 100 mL 84 kJ
Approx Osmolality 278 mOsm/kg

ISOTONIC

100 mL Intravenous Infusion

Glucose 5%

B

Bar Code
9 318242 000506

_
25

_
50

_
75

GLUCOSE 
dextrose monohydrate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9573
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	2.5 g  in 50 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9573-60	60 in 1 CARTON	10/05/2017	10/06/2017
1		50 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		10/05/2017	10/06/2017

GLUCOSE 
dextrose monohydrate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9569
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	5 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9569-48	48 in 1 CARTON	10/05/2017	10/06/2017
1		100 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		10/05/2017	10/06/2017

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Pty Ltd		750455891	ANALYSIS(0338-9573, 0338-9569) , MANUFACTURE(0338-9573, 0338-9569) , LABEL(0338-9573, 0338-9569) , PACK(0338-9573, 0338-9569) , STERILIZE(0338-9573, 0338-9569)

Revised: 11/2019

Document Id: 7a7e4f2b-7916-42c2-b9ae-8e314d8892b3

34391-3

Set id: ebc4ef22-524f-4fbd-a537-1e26c7c697f7

Version: 2

Effective Time: 20191115

 

Baxter Healthcare Corporation