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

Ceftriaxone 1 g Representative Container Label NDC 0338-5002
(click image for full-size original)

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

Ceftriaxone Representative Carton Label -- 1 g -- Panel 1 -- NDC 0338-5002
(click image for full-size original)

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

Ceftriaxone Representative Carton Label -- 1 g -- Panel 2 -- NDC 0338-5002
(click image for full-size original)

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.

Ceftriaxone 2 g Container Label NDC 0338-5003
(click image for full-size original)

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

Ceftriaxone Representative Carton Label -- 2 g -- Panel 1 -- NDC 0338-5003
(click image for full-size original)

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

Ceftriaxone Representative Carton Label -- 2 g -- Panel 2 -- NDC 0338-5003
(click image for full-size original)

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.

CEFTRIAXONE ceftriaxone sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-5002
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM (CEFTRIAXONE) CEFTRIAXONE 1 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE 1.9 g in 50 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-5002-41 24 BAG in 1 CASE contains a BAG
1 50 mL in 1 BAG This package is contained within the CASE (0338-5002-41)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065224 08/23/2005
CEFTRIAXONE ceftriaxone sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-5003
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM (CEFTRIAXONE) CEFTRIAXONE 2 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE 1.2 g in 50 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-5003-41 24 BAG in 1 CASE contains a BAG
1 50 mL in 1 BAG This package is contained within the CASE (0338-5003-41)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065224 08/23/2005
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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