FDA.reportPublic FDA data

DEXTROSE

Product NDC
0338-0017
11-digit product format
003380017
Labeler code
0338
Product ID
0338-0017_31bb4a5f-733e-4354-9fbf-138dede4db0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE MONOHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA016673
Marketing category
NDA
Marketing start
1971-03-04
Substance
DEXTROSE MONOHYDRATE
Active strength
50 g/1000mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DEXTROSE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE50 g/1000mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G
Rxcui1795477, 1795480, 1795481, 1795607, 1795609, 1795610, 1795612, 1795616, 1795618

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-0017-02DEXTROSE250 mL in 1 BAGINJECTION, SOLUTION25021
0338-0017-03DEXTROSE500 mL in 1 BAGINJECTION, SOLUTION50021
0338-0017-04DEXTROSE1000 mL in 1 BAGINJECTION, SOLUTION100021
0338-0017-10DEXTROSE25 mL in 1 BAGINJECTION, SOLUTION2521
0338-0017-10DEXTROSE4 in 1 POUCHINJECTION, SOLUTION421
0338-0017-11DEXTROSE4 in 1 POUCHINJECTION, SOLUTION421
0338-0017-11DEXTROSE50 mL in 1 BAGINJECTION, SOLUTION5021
0338-0017-18DEXTROSE100 mL in 1 BAGINJECTION, SOLUTION10021
0338-0017-18DEXTROSE4 in 1 POUCHINJECTION, SOLUTION421
0338-0017-31DEXTROSE16 in 1 POUCHINJECTION, SOLUTION1621
0338-0017-31DEXTROSE50 mL in 1 BAGINJECTION, SOLUTION5021
0338-0017-38DEXTROSE16 in 1 POUCHINJECTION, SOLUTION1621
0338-0017-38DEXTROSE100 mL in 1 BAGINJECTION, SOLUTION10021
0338-0017-41DEXTROSE1 in 1 PACKAGEINJECTION, SOLUTION121
0338-0017-41DEXTROSE50 mL in 1 BAGINJECTION, SOLUTION5021
0338-0017-48DEXTROSE1 in 1 PACKAGEINJECTION, SOLUTION121
0338-0017-48DEXTROSE100 mL in 1 BAGINJECTION, SOLUTION10021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0017DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]21Current NDC, Legacy NDC, 17 package rows20250315_3bb406a9-f5cb-403a-b1bb-5c4facbea3d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795481dextrose 10 % in 1000 ML InjectionPSN3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795480dextrose 10 % in 250 ML InjectionPSN3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795477dextrose 10 % in 500 ML InjectionPSN3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795609dextrose 5 % in 100 ML InjectionPSN3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795612dextrose 5 % in 1000 ML InjectionPSN3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795618dextrose 5 % in 25 ML InjectionPSN3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795610dextrose 5 % in 250 ML InjectionPSN3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795616dextrose 5 % in 50 ML InjectionPSN3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795607dextrose 5 % in 500 ML InjectionPSN3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795609100 ML glucose 50 MG/ML InjectionSCD3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
17954811000 ML glucose 100 MG/ML InjectionSCD3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
17956121000 ML glucose 50 MG/ML InjectionSCD3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
179561825 ML glucose 50 MG/ML InjectionSCD3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795480250 ML glucose 100 MG/ML InjectionSCD3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795610250 ML glucose 50 MG/ML InjectionSCD3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
179561650 ML glucose 50 MG/ML InjectionSCD3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795477500 ML glucose 100 MG/ML InjectionSCD3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795607500 ML glucose 50 MG/ML InjectionSCD3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795481dextrose 10 % per 1000 ML InjectionSY3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795480dextrose 10 % per 250 ML InjectionSY3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795477dextrose 10 % per 500 ML InjectionSY3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795609dextrose 5 % per 100 ML InjectionSY3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795612dextrose 5 % per 1000 ML InjectionSY3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795618dextrose 5 % per 25 ML InjectionSY3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795610dextrose 5 % per 250 ML InjectionSY3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795616dextrose 5 % per 50 ML InjectionSY3bb406a9-f5cb-403a-b1bb-5c4facbea3d521
1795607dextrose 5 % per 500 ML InjectionSY3bb406a9-f5cb-403a-b1bb-5c4facbea3d521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0017-0100338001701150 mL in 1 BAG (0338-0017-01) 150 ml1971-03-040000-00-00NoNoCurrent
0338-0017-0200338001702250 mL in 1 BAG (0338-0017-02) 250 ml1971-03-040000-00-00NoNoCurrent
0338-0017-0300338001703500 mL in 1 BAG (0338-0017-03) 500 ml1971-03-040000-00-00NoNoCurrent
0338-0017-04003380017041000 mL in 1 BAG (0338-0017-04) 1000 ml1971-03-040000-00-00NoNoCurrent
0338-0017-10003380017104 BAG in 1 POUCH (0338-0017-10) / 25 mL in 1 BAG4 bag1971-03-040000-00-00NoNoCurrent
0338-0017-11003380017114 BAG in 1 POUCH (0338-0017-11) / 50 mL in 1 BAG4 bag1971-03-040000-00-00NoNoCurrent
0338-0017-18003380017184 BAG in 1 POUCH (0338-0017-18) / 100 mL in 1 BAG4 bag1971-03-040000-00-00NoNoCurrent
0338-0017-310033800173116 BAG in 1 POUCH (0338-0017-31) / 50 mL in 1 BAG16 bag1971-03-040000-00-00NoNoCurrent
0338-0017-380033800173816 BAG in 1 POUCH (0338-0017-38) / 100 mL in 1 BAG16 bag1971-03-040000-00-00NoNoCurrent
0338-0017-41003380017411 BAG in 1 PACKAGE (0338-0017-41) / 50 mL in 1 BAG1 bag1971-03-040000-00-00NoNoCurrent
0338-0017-48003380017481 BAG in 1 PACKAGE (0338-0017-48) / 100 mL in 1 BAG1 bag1971-03-040000-00-00NoNoCurrent