NDC Code(s) : 0338-3410-50, 0338-3410-24, 0338-3612-50, 0338-3612-24, 0338-3814-50, 0338-3814-24
Packager : Baxter Healthcare Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clindamycin phosphateClindamycin phosphate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-3410
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE(UNII: EH6D7113I8)
(CLINDAMYCIN - UNII:3U02EL437C) 		CLINDAMYCIN PHOSPHATE300 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)2 mg in 50 mL
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)2.50 g in 50 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0338-3410-2424 in 1 CARTON 28/06/2017
1NDC:0338-3410-5050 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
ANDA ANDA208084 06/28/2017
Clindamycin phosphateClindamycin phosphate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-3612
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE(UNII: EH6D7113I8)
(CLINDAMYCIN - UNII:3U02EL437C) 		CLINDAMYCIN PHOSPHATE600 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)2 mg in 50 mL
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)2.50 g in 50 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0338-3612-2424 in 1 CARTON 28/06/2017
1NDC:0338-3612-5050 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
ANDA ANDA208084 06/28/2017
Clindamycin phosphateClindamycin phosphate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-3814
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE(UNII: EH6D7113I8)
(CLINDAMYCIN - UNII:3U02EL437C) 		CLINDAMYCIN PHOSPHATE900 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)2 mg in 50 mL
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)2.5 g in 50 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0338-3814-2424 in 1 CARTON 28/06/2017
1NDC:0338-3814-5050 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
ANDA ANDA208084 06/28/2017

LABELER - Baxter Healthcare Corporation(005083209)

Establishment
Name Address ID/FEI Business Operations
Baxter Healthcare Corporation 194684502 ANALYSIS(0338-3410, 0338-3612, 0338-3814), LABEL(0338-3814, 0338-3612, 0338-3814), MANUFACTURE(0338-3410, 0338-3612, 0338-3814), PACK(0338-3410, 0338-3612, 0338-3814), STERILIZE(0338-3410, 0338-3612, 0338-3814)

PRINCIPAL DISPLAY PANEL

Representative Container Label NDC 0338-3410-50 panel 1 of 2Representative Container Label NDC 0338-3410-50 panel 1 of 2Container Label

NDC 0338-3410-50
Clindamycin Injection USP
In 5% Dextrose
300 mg per 50 mL (6 mg / mL)

GALAXY

Code 2G3452

50 mL Single Dose Container
Discard unused portion
For Intravenous Use.

Sterile Nonpyrogenic

Not for rapid injection or Intravenous push.

Each 50 mL contains: Clindamycin phosphate, USP equivalent to 300 mg
clindamycin, 2.5 g dextrose hydrous, USP, 2 mg edetate disodium
dihydrate, USP, and Water for Injection, USP. pH may have been adjusted
with sodium hydroxide and/or hydrochloric acid.

Dosage: See prescribing information.

Cautions: Do not add supplementary medication. Must not be used in
series connections. Check for minute leaks and solution clarity.

Rx only

Store at 20°C to 25°C (68° to 77°F)[see USP Controlled Room Temperature].
Avoid temperatures above 30°C.

Baxter Logo

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Made in USA

07-34-00-2145

BAR CODE POSITION ONLY
303383410504

Representative Container Label NDC 0338-3410-50 panel 1 of 2Representative Container Label NDC 0338-3410-50 panel 1 of 2Carton Label

GALAXY Container

Baxter Logo

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015
Made in USA

07-04-00-1225

Clindamycin Injection USP in 5% Dextrose
300 mg per 50 mL (6 mg / mL)
Contains 12 - 50 mL Single Dose Containers
Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Avoid temperatures above 30°C.

Rx only

NDC 0338-3410-24
Code 2G3452

*FOR BAR CODE POSITION ONLY

(01) 20303383410249

For Intravenous Use.
Not for rapid injection or Intravenous push.

Sterile Nonpyrogenic

Each 50 mL contains: Clindamycin phosphate, USP equivalent to 300 mg clindamycin, 2.5 g dextrose
hydrous, USP, 2 mg edetate disodium dihydrate, USP, and Water for Injection, USP. pH may have been
adjusted with sodium hydroxide and/or hydrochloric acid.
Dosage: See prescribing information.
Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks and solution clarity.

Representative Container Label NDC 0338-3410-50 panel 1 of 2Representative Container Label NDC 0338-3410-50 panel 1 of 2Container Label

NDC 0338-3612-50
Clindamycin Injection USP
In 5% Dextrose
600 mg per 50 mL
(12 mg / mL)

GALAXY

Code 2G3453

50 mL Single Dose Container
Discard unused portion
For Intravenous Use.

Not for rapid injection or Intravenous push.

Sterile Nonpyrogenic

Each 50 mL contains: Clindamycin phosphate, USP equivalent to 600 mg
clindamycin, 2.5 g dextrose hydrous, USP, 2 mg edetate disodium
dihydrate, USP, and Water for Injection, USP. pH may have been adjusted
with sodium hydroxide and/or hydrochloric acid.

Dosage: See prescribing information.

Cautions: Do not add supplementary medication. Must not be used in
series connections. Check for minute leaks and solution clarity.

Rx only

Store at 20°C to 25°C (68° to 77°F)[see USP Controlled Room Temperature].
Avoid temperatures above 30°C.

Baxter Logo

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Made in USA

07-34-00-2146

BAR CODE POSITION ONLY
303383612502

Representative Container Label NDC 0338-3410-50 panel 1 of 2Representative Container Label NDC 0338-3410-50 panel 1 of 2Carton Label

GALAXY Container

Baxter Logo

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015
Made in USA

07-04-00-1226

Clindamycin Injection USP in 5% Dextrose
600 mg per 50 mL (12 mg / mL)
Contains 12 - 50 mL Single Dose Containers
Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Avoid temperatures above 30°C.

Rx only

NDC 0338-3612-24
Code 2G3453

*FOR BAR CODE POSITION ONLY

(01) 20303383612247

For Intravenous Use.
Not for rapid injection or Intravenous push.

Sterile Nonpyrogenic

Each 50 mL contains: Clindamycin phosphate, USP equivalent to 600 mg clindamycin, 2.5 g dextrose
hydrous, USP, 2 mg edetate disodium dihydrate, USP, and Water for Injection, USP. pH may have been
adjusted with sodium hydroxide and/or hydrochloric acid.
Dosage: See prescribing information.
Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks and solution clarity.

Representative Container Label NDC 0338-3410-50 panel 1 of 2Representative Container Label NDC 0338-3410-50 panel 1 of 2Container Label

NDC 0338-3814-50
Clindamycin Injection USP
In 5% Dextrose
900 mg per 50 mL (18 mg / mL)

GALAXY

Code 2G3454

50 mL Single Dose Container
Discard unused portion
For Intravenous Use.

Sterile Nonpyrogenic

Not for rapid injection or Intravenous push.

Each 50 mL contains: Clindamycin phosphate, USP equivalent to 900 mg
clindamycin, 2.5 g dextrose hydrous, USP, 2 mg edetate disodium
dihydrate, USP, and Water for Injection, USP. pH may have been adjusted
with sodium hydroxide and/or hydrochloric acid.

Dosage: See prescribing information.

Cautions: Do not add supplementary medication. Must not be used in
series connections. Check for minute leaks and solution clarity.

Rx only

Store at 20°C to 25°C (68° to 77°F)[see USP Controlled Room Temperature].
Avoid temperatures above 30°C.

Baxter Logo

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Made in USA

07-34-00-2147

BAR CODE POSITION ONLY
303383814500

Representative Container Label NDC 0338-3410-50 panel 1 of 2Representative Container Label NDC 0338-3410-50 panel 1 of 2Carton Label

GALAXY Container

Baxter Logo

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015
Made in USA

07-04-00-1227

Clindamycin Injection USP in 5% Dextrose
900 mg per 50 mL (18 mg / mL)
Contains 12 - 50 mL Single Dose Containers
Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Avoid temperatures above 30°C.

Rx only

NDC 0338-3814-24
Code 2G3454

*FOR BAR CODE POSITION ONLY

(01) 20303383814245

For Intravenous Use.
Not for rapid injection or Intravenous push.

Sterile Nonpyrogenic

Each 50 mL contains: Clindamycin phosphate, USP equivalent to 900 mg clindamycin, 2.5 g dextrose
hydrous, USP, 2 mg edetate disodium dihydrate, USP, and Water for Injection, USP. pH may have been
adjusted with sodium hydroxide and/or hydrochloric acid.
Dosage: See prescribing information.
Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks and solution clarity.