Glucose
FDA Label NDC 0338-9787

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Baxter Healthcare Company for the product Glucose (NDC 0338-9787). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package/Label Principal Display Panel

Container Label 0338-9787-01 (Image 08)

Container Label 0338-9787-01 (Image 08)

Container Label

Code B0257 3000 ml

Baxter Logo

Glucose 50% w/v
Concentrate for solution for infusion

VIAFLEX container Hypertonic
Free from bacterial endotoxins

Formula per 1000 ml
Anhydrous Glucose
Water for Injections
HCI for pH adjustment
Megajoules (approx.)

500 g

8.4 (2000 kcal)

50%

Dilute before use – bulk source container
Not for direct intravenous infusion

For use under medical supervision
For intravenous use following dilution under aseptic conditions
Check compatibility with other admixture components before use
Keep out of the sight and reach of children
Do not store above 25°C
Do not use unless solution is clear and container is undamaged
Single use only Do not store partially used containers
Discard any unused portion, waste materials and all associated
devices
Do not administer simultaneously with blood or, before
or after, using the same transfusion equipment
Discontinue infusion if adverse reaction occurs

Baxter Healthcare Ltd
Caxton Way Thetford
Norfolk IP24 3SE UK

LOT EXP

POM

PL 00116/0271
TH-35-01-934

Carton Label 0338-9878-01 (Image 09)

Carton Label 0338-9878-01 (Image 09)

Carton Label

Baxter Logo
Code FKB0257B

Glucose 50% w/v
Concentrate for
solution for infusion

Hypertonic

Do not store above 25°C
Keep out of sight and reach of children

Baxter Healthcare Ltd
Caxton Way, Thetford, Norfolk, IP24 3SE, UK

POM

LOT: EXP:

4 x 3000 ml
(≈15.5 kg)

50%

PL 00116/0271
TH-25-02-116

Baxter Logo
Code FKB0257B

Glucose 50% w/v
Concentrate for
solution for infusion

Hypertonic

POM

4 x 3000 ml
(≈15.5 kg)

50%

LOT: EXP:

Container Label 0338-9785-01 (Image 10)

Container Label 0338-9785-01 (Image 10)

Container Label

1 –

-

2-

-

3-

-

4-

Code B0273 500 ml

Baxter Logo

Glucose 70% w/v
Concentrate for solution for infusion

VIAFLEX container Hypertonic
Free from bacterial endotoxins

Formula per 1000 ml
Anhydrous Glucose
Water for Injections
HCI for pH adjustment
Megajoules (approx.)

700 g

11.8 (2800 kcal)

70%

Dilute before use – bulk source container
Not for direct intravenous infusion

For use under medical supervision
For intravenous use following dilution under aseptic conditions
Check compatibility with other admixture components before use
Keep out of the sight and reach of children
Do not store above 25°C
Do not use unless solution is clear and container is undamaged
Single use only Do not store partially used containers
Discard any unused portion, waste materials and all associated devices
Do not administer simultaneously with blood or, before or after, using
the same transfusion equipment
Discontinue infusion if adverse reaction occurs

Baxter Healthcare Ltd
Caxton Way Thetford
Norfolk IP24 3SE UK

Lot Expiry

POM
PL 00116/0272
TH-35-01-931

-1

-

-2

-

-3

-

-4

Carton Label 0338-9785-01 (Image 11)

Carton Label 0338-9785-01 (Image 11)

Carton Label

Baxter Logo
Code FKB0273B

Glucose 70% w/v
Concentrate for
solution for infusion

Hypertonic

Do not store above 25°C
Keep out of sight and reach of children

Baxter Healthcare Ltd
Caxton Way, Thetford, Norfolk, IP24 3SE, UK

LOT: EXP:

20 x 500 ml
(≈15.0 kg)

70%

POM
PL 00116/0272
TH-25-02-117

Baxter Logo
Code FKB0273B

Glucose 70% w/v
Concentrate for
solution for infusion

Hypertonic

20 x 500 ml
(≈15.0 kg)

70%

POM
PL 00116/0272

LOT: EXP:

* Please review the disclaimer below.