Ceftriaxone (Page 6 of 6)
HOW SUPPLIED/STORAGE AND HANDLING
Ceftriaxone Injection, USP is supplied premixed as a frozen, iso-osmotic, sterile, nonpyrogenic solution of ceftriaxone sodium in a case of 24 x 50 mL single dose GALAXY containers (PL 2040 plastic). The following strengths are available:
1 gm equivalent of ceftriaxone, iso-osmotic with approximately 1.9 gm Dextrose Hydrous, USP, added (NDC 0338-5002-41).
2 gm equivalent of ceftriaxone, iso-osmotic with approximately 1.2 gm Dextrose Hydrous, USP, added (NDC 0338-5003-41).
NOTE: Store Ceftriaxone Injection, USP in the frozen state at or below -20°C/-4°F. See DIRECTIONS FOR USE:
Handle frozen product containers with care. Product containers may be fragile in the frozen state.
Baxter Healthcare Corporation Deerfield, IL 60015 USA
Printed in USA
Baxter and Galaxy are registered trademarks of Baxter International Inc.
ATCC is a trademark of the American Type Culture Collection.
07-19-03-865
Rev. January 2022
PACKAGE LABEL — PRINCIPAL DISPLAY PANEL
Container Label 1 g
Container Label 1 g
Baxter
Ceftriaxone
Injection, USP (In Dextrose)
1 g
GALAXY
Single Dose
Container
50 mL
Iso-osmotic
NDC 0338-5002-41
Code 2G3505
Sterile Nonpyrogenic
Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 1 g ceftriaxone with
approx. 1.9 g Dextrose Hydrous, USP, added to adjust osmolality. pH may have
been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0.
Usual Dosage: See package insert.
Cautions: Administer IV using sterile equipment. Must not be used in series
connections. Do not add supplementary medication. Check for minute leaks and
solution clarity. Rx only.
Store at or below -20°C (-4°F). Thaw at room temperature (25°C/77°F) or
under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION
IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze.
Baxter and GALAXY are trademarks of Baxter International Inc.
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in USA
PL 2040 Plastic
07-34-63-668
*BAR CODE POSITION ONLY 303385002417
Carton Label — 1 g — Panel 1
Carton Label — 1 g — Panel 1
Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE
THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature.
Do not refreeze.
Handle frozen product containers with care. Product containers may be fragile in the frozen state.
Baxter and Galaxy are registered trademarks of Baxter International Inc.
PL 2040 Plastic
07-04-65-179
Baxter Logo
Ceftriaxone Injection, USP (In Dextrose)
12 — 50 mL Single-Dose Containers Iso-osmotic
Store at or below -20°C/-4°F. Do not refreeze.
Rx only
1 g
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE
THAW BYIMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.
The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature.
Do not refreeze.
Handle frozen product containers with care. Product containers may be fragile in the frozen state.
Baxter and Galaxy are registered trademarks of Baxter International Inc.
PL 2040 Plastic
07-04-65-179
Baxter Logo
Ceftriaxone Injection, USP (In Dextrose)
12 — 50 mL Single-Dose Containers Iso-osmotic
Store at or below -20°C/-4°F. Do not refreeze.
Rx only
1 g
Baxter Healthcare Corporation Deerfield, IL 60015 USA
Carton Label — 1 g — Panel 2
Carton Label — 1 g — Panel 2
NDC 0338-5002-41
Code 2G3504
*FOR BAR CODE POSITION ONLY
(01) 503385002412
GALAXY Container
Sterile Nonpyrogenic
Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 1 g ceftriaxone with approx.
1.9 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with
sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0.
Usual dosage: See package insert.
Cautions: Administer IV using sterile equipment. Must not be used in series connections.
Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.
NDC 0338-5002-41
Code 2G3504
*FOR BAR CODE POSITION ONLY
(01) 503385002412
GALAXY Container
Sterile Nonpyrogenic
Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 1 g ceftriaxone with approx.
1.9 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with
sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0.
Usual dosage: See package insert.
Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.
Baxter Logo
Ceftriaxone
Injection, USP (In Dextrose)
2 g
GALAXY
Single Dose
Container
50 mL
Iso-osmotic
NDC 0338-5003-41
Code 2G3505
Sterile Nonpyrogenic
Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 2 g ceftriaxone with
approx. 1.2 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have
been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0.
Usual dosage: See package insert.
Cautions: Administer IV using sterile equipment. Must not be used in series
connections. Do not add supplementary medication. Check for minute leaks and
solution clarity. Rx only.
Store at or below -20°C (-4°F). Thaw at room temperature (25°C/77°F) or under
refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER
BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days
under refrigeration or 48 hours at room temperature. Do not refreeze.
Baxter and GALAXY are trademarks of
Baxter International Inc.
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in USA
PL 2040 Plastic
07-34-63-670
*BAR CODE POSITION ONLY 303385003414
Carton Label — 2 g — Panel 1
Carton Label — 2 g — Panel 1
Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE
THAW BYIMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.
The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature.
Do not refreeze.
Handle frozen product containers with care. Product containers may be fragile in the frozen state.
Baxter and Galaxy are registered trademarks of Baxter International Inc.
PL 2040 Plastic
07-04-65-180
Baxter Logo
Ceftriaxone Injection, USP (In Dextrose)
12 — 50 mL Single-Dose Containers Iso-osmotic
Store at or below -20°C/-4°F. Do not refreeze.
Rx only
2 g
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE
THAW BYIMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.
The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature.
Do not refreeze.
Handle frozen product containers with care. Product containers may be fragile in the frozen state.
Baxter and Galaxy are registered trademarks of Baxter International Inc.
PL 2040 Plastic
07-04-65-180
Baxter Logo
Ceftriaxone Injection, USP (In Dextrose)
12 — 50 mL Single-Dose Containers Iso-osmotic
Store at or below -20°C/-4°F. Do not refreeze.
Rx only
2 g
Baxter Healthcare Corporation Deerfield, IL 60015 USA
Carton Label — 2 g — Panel 2
Carton Label — 2 g — Panel 2
NDC 0338-5003-41
Code 2G3505
*FOR BAR CODE POSITION ONLY
(01) 503385003419
GALAXY Container
Sterile Nonpyrogenic
Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 2 g ceftriaxone with approx.
1.2 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with
sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0.
Usual dosage: See package insert.
Cautions: Administer IV using sterile equipment. Must not be used in series connections.
Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.
NDC 0338-5003-41
Code 2G3505
*FOR BAR CODE POSITION ONLY
(01) 503385003419
GALAXY Container
Sterile Nonpyrogenic
Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 2 g ceftriaxone with approx.
1.2 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with
sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0.
Usual dosage: See package insert.
Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.
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| Labeler — Baxter Healthcare Corporation (005083209) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Baxter Healthcare Corporation | 194684502 | MANUFACTURE (0338-5002), MANUFACTURE (0338-5003), ANALYSIS (0338-5002), ANALYSIS (0338-5003), LABEL (0338-5002), LABEL (0338-5003), PACK (0338-5002), PACK (0338-5003), STERILIZE (0338-5002), STERILIZE (0338-5003) | |
Revised: 01/2022 Baxter Healthcare Corporation
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