NDC Code(s) : 0338-9555-24, 0338-9557-12
Packager : Baxter Healthcare Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9555
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMEDETOMIDINE HYDROCHLORIDE(UNII: 1018WH7F9I)
(DEXMEDETOMIDINE - UNII:67VB76HONO) 		DEXMEDETOMIDINE200 ug in 50 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)450 mg in 50 mL
SODIUM ACETATE(UNII: 4550K0SC9B)
ACETIC ACID(UNII: Q40Q9N063P)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0338-9555-2424 in 1 CARTON 21/08/2018
150 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 ANDA208532 08/21/2018
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9557
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMEDETOMIDINE HYDROCHLORIDE(UNII: 1018WH7F9I)
(DEXMEDETOMIDINE - UNII:67VB76HONO) 		DEXMEDETOMIDINE400 ug in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)900 mg in 100 mL
SODIUM ACETATE(UNII: 4550K0SC9B)
ACETIC ACID(UNII: Q40Q9N063P)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0338-9557-1212 in 1 CARTON 21/08/2018
1100 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 ANDA208532 08/21/2018

LABELER - Baxter Healthcare Company(005083209)

Establishment
Name Address ID/FEI Business Operations
Baxter Healthcare Corporation 194684502 ANALYSIS(0338-9555, 0338-9557), LABEL(0338-9555, 0338-9557), MANUFACTURE(0338-9555, 0338-9557), PACK(0338-9555, 0338-9557), STERILIZE(0338-9555, 0338-9557)

PRINCIPAL DISPLAY PANEL

Dex Med Representative Container Label 0338-9555-24Container Label

NDC 0338-9555-24

Dexmedetomidine Hydrochloride in
0.9% Sodium Chloride Injection

200 mcg per 50 mL
(4 mcg / mL)*

GALAXY
50 mL Single Dose Container
Discard unused portion
For Intravenous Infusion
Code 2G3496

*Each mL contains: 4 mcg dexmedetomidine provided as 4.72 mcg
dexmedetomidine HCI, USP; 9 mg sodium chloride, USP; 483 mcg sodium acetate
trihydrate, USP; 87 mcg glacial acetic acid, USP; and Water for
Injection, USP. pH is 4.5 to 5.5.

Usual Dosage: See prescribing information.

Rx only

Store at 20° to 25°C (68° to 77°F)[See USP Controlled Room Temperature].

Do not freeze.

PL 2501 Plastic

Baxter Logo
Baxter and Galaxy are registered trademarks of Baxter International Inc.

Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Made in USA

07-34-75-903

Dex Med Representative Container Label 0338-9555-24Dex Med Representative Container Label 0338-9555-24Carton Label

GALAXY Container
PL 2501 Plastic

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

07-04-75-905

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
Rx Only
NDC 0338-9555-24
200 mcg per 50 mL (4 mcg / mL)*
Code 2G3496

*FOR BAR CODE POSITION ONLY
(01) 20303389555241

For Intravenous Infusion
*Each mL contains: 4 mcg dexmedetomidine provided as 4.72 mcg dexmedetomidine HCl, USP; 9 mg sodium
chloride, USP; 483 mcg sodium acetate trihydrate, USP; 87 mcg glacial acetic acid, USP; and Water for Injection,
USP. pH is 4.5 to 5.5.

Usual Dosage: See prescribing information.

Dex Med Representative Container Label 0338-9555-24Container Label

NDC 0338-9557-12

Dexmedetomidine Hydrochloride in
0.9% Sodium Chloride Injection

400 mcg per 100 mL
(4 mcg / mL)*

GALAXY
Code 2G3497
100 mL Single Dose Container
Discard unused portion
For Intravenous Infusion

*Each mL contains: 4 mcg dexmedetomidine provided as 4.72 mcg
dexmedetomidine HCl, USP; 9 mg sodium chloride, USP; 483 mcg
sodium acetate trihydrate, USP; 87 mcg glacial acetic acid, USP; and
Water for Injection, USP. pH is 4.5 to 5.5.

Usual Dosage: See prescribing information.

Rx only

Store at 20° to 25°C (68° to 77°F)[See USP Controlled Room
Temperature].

Do not freeze.

PL 2501 Plastic

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

07-34-75-904

Dex Med Representative Container Label 0338-9555-24Dex Med Representative Container Label 0338-9555-24Carton Label

GALAXY Container
PL 2501 Plastic

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

07-04-75-906

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
Rx Only
NDC 0338-9557-12
400 mcg per 100 mL (4 mcg / mL)*
Code 2G3497

Contains 6 (1 x 6) 100 mL Single Dose Containers
Store at 20° to 25°C (68° to 77°F)[See USP Controlled Room Temperature]. Do not freeze.

*FOR BAR CODE POSITION ONLY
(01) 20303389557122

For Intravenous Infusion

*Each mL contains: 4 mcg dexmedetomidine provided as 4.72 mcg dexmedetomidine HCl, USP; 9 mg sodium
chloride, USP; 483 mcg sodium acetate trihydrate, USP; 87 mcg glacial acetic acid, USP; and Water for Injection,
USP. pH is 4.5 to 5.5.

Usual Dosage: See prescribing information.