NDC Code(s) : 0264-7510-00, 0264-7510-10, 0264-7510-20, 0264-7520-00, 0264-7520-10, 0264-7520-20
Packager : B. Braun Medical Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DEXTROSEDEXTROSE SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-7510
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE, UNSPECIFIED FORM5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0264-7510-0012 in 1 CASE 02/02/1988
11000 mL in 1 CONTAINER Type 0: Not a Combination Product
2NDC:0264-7510-1024 in 1 CASE 02/02/1988
2500 mL in 1 CONTAINER Type 0: Not a Combination Product
3NDC:0264-7510-2024 in 1 CASE 02/02/1988
3250 mL in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019626 02/02/1988
DEXTROSEDEXTROSE SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-7520
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 		DEXTROSE, UNSPECIFIED FORM10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0264-7520-0012 in 1 CASE 02/02/1988
11000 mL in 1 CONTAINER Type 0: Not a Combination Product
2NDC:0264-7520-1024 in 1 CASE 02/02/1988
2500 mL in 1 CONTAINER Type 0: Not a Combination Product
3NDC:0264-7520-2024 in 1 CASE 02/02/1988
3250 mL in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019626 02/02/1988

LABELER - B. Braun Medical Inc.(002397347)

PRINCIPAL DISPLAY PANEL

5% Dextrose
Injection USP

REF L5100
NDC 0264-7510-00
DIN 01924281
HK 22598

1000 mL
EXCEL® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g;
Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 250 mOsmol/liter

Sterile, nonpyrogenic. Single dose container. Do not use in
series connection. For intravenous use only. Use only if
solution is clear and container and seals are intact.

WARNINGS: ELECTROLYTE-FREE DEXTROSE SOLUTIONS
SHOULD NOT BE GIVEN CONJOINTLY WITH BLOOD BECAUSE
AGGLOMERATION MAY OCCUR. Some additives may be
incompatible. Consult with pharmacist. When introducing
additives, use aseptic techniques. Mix thoroughly.
Do not store.

Recommended Storage: Room temperature (25°C). Avoid
excessive heat. Protect from freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the
overwrap, check for minute leaks by squeezing container firmly. If
leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

EXCEL is a registered trademark of B. Braun Medical Inc.

7
OTHER

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
www.bbraun.com

In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4

Y94-003-242
LD-111-3

EXP

LOT

1000 mL Container Label L5100

PRINCIPAL DISPLAY PANEL

5% Dextrose Injection USP

REF L5101
NDC 0264-7510-10

DIN 01924281
HK 22598

500 mL
EXCEL® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g;
Water for Injection USP qs
pH: 4.4 (3.5-6.5); Calc. Osmolarity: 250 mOsmol/liter

Sterile, nonpyrogenic. Single dose container. Do not use in series
connection. For intravenous use only. Use only if solution is clear and
container and seals are intact.

WARNINGS: ELECTROLYTE-FREE DEXTROSE SOLUTIONS SHOULD NOT BE
GIVEN CONJOINTLY WITH BLOOD BECAUSE AGGLOMERATION MAY OCCUR.
Some additives may be incompatible. Consult with pharmacist. When
introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Recommended Storage: Room temperature (25°C). Avoid excessive heat.
Protect from freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the overwrap, check
for minute leaks by squeezing container firmly. If leaks are found, discard
solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

7
OTHER

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
www.bbraun.com

In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4

Y94-003-240
LD-118-3

EXP

LOT

Y94-003-240Y94-003-240

PRINCIPAL DISPLAY PANEL

5% Dextrose
Injection USP

REF L5102
NDC 0264-7510-20
 DIN 01924281
HK 22598

250 mL
EXCEL® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 5 g;
Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 250 mOsmol/liter

Sterile, nonpyrogenic. Single dose container. Do not use in series
connection. For intravenous use only. Use only if solution is clear
and container and seals are intact.

WARNINGS: ELECTROLYTE-FREE DEXTROSE SOLUTIONS
SHOULD NOT BE GIVEN CONJOINTLY WITH BLOOD BECAUSE
AGGLOMERATION MAY OCCUR. Some additives may be
incompatible. Consult with pharmacist. When introducing
additives, use aseptic techniques. Mix thoroughly. Do not store.

Recommended Storage: Room temperature (25°C). Avoid
excessive heat. Protect from freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the
overwrap, check for minute leaks by squeezing container firmly. If
leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

EXCEL is a registered trademark of B. Braun Medical Inc.

7
OTHER

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
www.bbraun.com

In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4

Y94-003-238
LD-182-4

EXP

LOT

Y94-003-238Y94-003-238

PRINCIPAL DISPLAY PANEL

10% Dextrose
Injection USP

REF L5200
NDC 0264-7520-00
DIN 01924427
HK 22599

1000 mL
EXCEL® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 10 g;
Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 505 mOsmol/liter,
hypertonic

Sterile, nonpyrogenic. Single dose container. Do not use in
series connection. For intravenous use only. Use only if
solution is clear and container and seals are intact.

WARNINGS: ELECTROLYTE-FREE DEXTROSE SOLUTIONS
SHOULD NOT BE GIVEN CONJOINTLY WITH BLOOD BECAUSE
AGGLOMERATION MAY OCCUR. Some additives may be
incompatible. Consult with pharmacist. When introducing
additives, use aseptic techniques. Mix thoroughly.
Do not store.

Recommended Storage: Room temperature (25°C). Avoid
excessive heat. Protect from freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the
overwrap, check for minute leaks by squeezing container firmly. If
leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

EXCEL is a registered trademark of B. Braun Medical Inc.

7
OTHER

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
www.bbraun.com

In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4

Y94-003-241
LD-181-3

EXP

LOT

1000 mL Container Label L5200

PRINCIPAL DISPLAY PANEL

10% Dextrose Injection USP

REF L5201
NDC 0264-7520-10

DIN 01924427
HK 22599

500 mL
EXCEL® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 10 g;
Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 505 mOsmol/liter, hypertonic

Sterile, nonpyrogenic. Single dose container. Do not use in series
connection. For intravenous use only. Use only if solution is clear and
container and seals are intact.

WARNINGS: ELECTROLYTE-FREE DEXTROSE SOLUTIONS SHOULD NOT BE
GIVEN CONJOINTLY WITH BLOOD BECAUSE AGGLOMERATION MAY OCCUR.
Some additives may be incompatible. Consult with pharmacist. When
introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Recommended Storage: Room temperature (25°C). Avoid excessive heat.
Protect from freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing the overwrap, check
for minute leaks by squeezing container firmly. If leaks are found, discard
solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

EXCEL is a registered trademark of B. Braun Medical Inc.

7
OTHER

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
www.bbraun.com

In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4

Y94-003-239
LD-180-3

EXP

LOT

Y94-003-239Y94-003-239

PRINCIPAL DISPLAY PANEL

10% Dextrose
Injection USP

REF L5202
NDC 0264-7520-20
DIN 01924427
HK 22599

250 mL
EXCEL® CONTAINER

Each 100 mL contains: Hydrous Dextrose USP 10 g;
Water for Injection USP qs

pH: 4.4 (3.5-6.5); Calc. Osmolarity: 505 mOsmol/liter,
hypertonic

Sterile, nonpyrogenic. Single dose container. Do not use in series
connection. For intravenous use only. Use only if solution is clear
and container and seals are intact.

WARNINGS: ELECTROLYTE-FREE DEXTROSE SOLUTIONS
SHOULD NOT BE GIVEN CONJOINTLY WITH BLOOD BECAUSE
AGGLOMERATION MAY OCCUR. Some additives may be
incompatible. Consult with  pharmacist. When introducing
additives, use aseptic techniques. Mix thoroughly. Do not store.

Recommended Storage: Room temperature (25°C). Avoid excessive
heat. Protect from freezing. See Package Insert.

Do not remove overwrap until ready for use. After removing
the overwrap, check for minute leaks by squeezing container firmly. If
leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

EXCEL is a registered trademark of B. Braun Medical Inc.

7
OTHER

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
www.bbraun.com

In Canada, distributed by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4

Y94-003-237
LD-179-3

EXP

LOT

Y94-003-237Y94-003-237