NDC Code(s) : 0338-0017-10, 0338-0017-41, 0338-0017-11, 0338-0017-31, 0338-0017-48, 0338-0017-18, 0338-0017-38, 0338-0017-01, 0338-0017-02, 0338-0017-03, 0338-0017-04, 0338-0023-02, 0338-0023-03, 0338-0023-04
Packager : Baxter Healthcare Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DEXTROSEDEXTROSE MONOHYDRATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0017
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE50 g in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0338-0017-104 in 1 POUCH 03/04/1971
125 mL in 1 BAG Type 0: Not a Combination Product
2NDC:0338-0017-411 in 1 PACKAGE 03/04/1971
250 mL in 1 BAG Type 0: Not a Combination Product
3NDC:0338-0017-114 in 1 POUCH 03/04/1971
350 mL in 1 BAG Type 0: Not a Combination Product
4NDC:0338-0017-3116 in 1 POUCH 03/04/1971
450 mL in 1 BAG Type 0: Not a Combination Product
5NDC:0338-0017-481 in 1 PACKAGE 03/04/1971
5100 mL in 1 BAG Type 0: Not a Combination Product
6NDC:0338-0017-184 in 1 POUCH 03/04/1971
6100 mL in 1 BAG Type 0: Not a Combination Product
7NDC:0338-0017-3816 in 1 POUCH 03/04/1971
7100 mL in 1 BAG Type 0: Not a Combination Product
8NDC:0338-0017-01150 mL in 1 BAG Type 0: Not a Combination Product03/04/1971
9NDC:0338-0017-02250 mL in 1 BAG Type 0: Not a Combination Product03/04/1971
10NDC:0338-0017-03500 mL in 1 BAG Type 0: Not a Combination Product03/04/1971
11NDC:0338-0017-041000 mL in 1 BAG Type 0: Not a Combination Product03/04/1971
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016673 03/04/1971
DEXTROSEDEXTROSE MONOHYDRATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0023
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE MONOHYDRATE100 g in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0338-0023-02250 mL in 1 BAG Type 0: Not a Combination Product25/01/1971
2NDC:0338-0023-03500 mL in 1 BAG Type 0: Not a Combination Product25/01/1971
3NDC:0338-0023-041000 mL in 1 BAG Type 0: Not a Combination Product25/01/1971
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016694 01/25/1971

LABELER - Baxter Healthcare Corporation(005083209)

Establishment
Name Address ID/FEI Business Operations
Baxter Healthcare Corporation 059140764 ANALYSIS(0338-0017, 0338-0023), MANUFACTURE(0338-0017, 0338-0023), LABEL(0338-0017, 0338-0023), PACK(0338-0017, 0338-0023), STERILIZE(0338-0017, 0338-0023)

Establishment
Name Address ID/FEI Business Operations
Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0017, 0338-0023)

Establishment
Name Address ID/FEI Business Operations
Baxter Healthcare Corporation 091171389 ANALYSIS(0338-0017), MANUFACTURE(0338-0017), LABEL(0338-0017), PACK(0338-0017), STERILIZE(0338-0017)

Establishment
Name Address ID/FEI Business Operations
Baxter Healthcare Corporation 189326168 ANALYSIS(0338-0017, 0338-0023), MANUFACTURE(0338-0017, 0338-0023), LABEL(0338-0017, 0338-0023), PACK(0338-0017, 0338-0023), STERILIZE(0338-0017, 0338-0023)

Establishment
Name Address ID/FEI Business Operations
Baxter, S.A. de C.V. 810432484 ANALYSIS(0338-0017), MANUFACTURE(0338-0017), LABEL(0338-0017), PACK(0338-0017), STERILIZE(0338-0017)

Establishment
Name Address ID/FEI Business Operations
Bieffe Medital SA 464755693 ANALYSIS(0338-0017), LABEL(0338-0017), MANUFACTURE(0338-0017), PACK(0338-0017), STERILIZE(0338-0017)

PRINCIPAL DISPLAY PANEL

Dextrose Representative Container LabelContainer Label

Container Label

LOT

EXP

5% Dextrose
Injection USP

2B0061
NDC 0038-0017-01

150 mL

Each 100 mL contains
5 g DextroseHydrous
USP pH 4.0 (3.2 to 6.5)
Osmolarity 252 mOsmol/L (calc)
SterileNonpyrogenic Single dose
container Read package insert for full
information Additives may be
incompatible Dosage Intravenously as
directed by a physician Cautions
Squeeze and inspect inner bag which
maintains product sterility Discard if
leaks are found Must not be used in
series connections Do not administer
simultaneously with blood Do not
useunless solution is clear Rx Only
Store unit in moisture barrier overwrap
at room temperature(25°C/77°F) until
ready to use Avoid excessive heat See
insert

Viaflex container PL146 plastic

BAXTER VIAFLEX and PL 146 are
trademarks of Baxter International Inc

For product information 1-800-933-0303

Baxter
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in USA

Dextrose Representative Container LabelContainer Label

Container Label

LOT

EXP

2B0063
NDC 0038-0023-03
DIN 00060364

10% Dextrose
Injection USP

500 mL

Each 100 mL contain 10 g Dextrose Hydrous USP
pH 4.0 (3.2 to 6.5) Hypertonic Osmolarity 505
mOsmol/L (calc) Sterile Nonpyrogenic Single dose
container Additives may be incompatible Consult with
pharmacist if available When introducing additives use
aseptic technique Mix thorouhly Do not store
Dosage Intravenously as directed by a physician See
cirections Cautions Squeeze and inspect inner bag
which maintains product sterility Discard if leaks are
found Must not be used in series connections Do not
administer simultaneously with blood Do not use
unless solution is clear Rx Only Store unit in
moisture barrier overwrap at room temperature
(25°C/77°F) until ready to use Avoid excessive heat
See insert

Viaflex container PL 146 plastic

BAXTER VIAFLEX and PL 146 are trademarks of
Baxter International Inc

For product information 1-800-933-0303

Baxter logo
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in USA

Distribute in Canada By
Baxter Corporation
Toronto Ontario Canada