FDA.reportPublic FDA data

Dextrose

Product NDC
0338-9666
11-digit product format
003389666
Labeler code
0338
Product ID
0338-9666_bfc4224a-2fc9-4137-b4c6-9d2d6d948413
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextrose monohydrate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
NDA020179
Marketing category
NDA
Marketing start
1992-12-07
Substance
DEXTROSE MONOHYDRATE
Active strength
5 g/100mL
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G

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
0338-9666-35Dextrose35 in 1 CARTONINJECTION351
0338-9666-35Dextrose100 mL in 1 BAGINJECTION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9666-35ML - Milliliter0338-966617f21b28-ee52-444b-a626-3ddcb632dd0012025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795609dextrose 5 % in 100 ML InjectionPSNbfc4224a-2fc9-4137-b4c6-9d2d6d9484131
1795616dextrose 5 % in 50 ML InjectionPSNbfc4224a-2fc9-4137-b4c6-9d2d6d9484131
1795609100 ML glucose 50 MG/ML InjectionSCDbfc4224a-2fc9-4137-b4c6-9d2d6d9484131
179561650 ML glucose 50 MG/ML InjectionSCDbfc4224a-2fc9-4137-b4c6-9d2d6d9484131
1795609dextrose 5 % per 100 ML InjectionSYbfc4224a-2fc9-4137-b4c6-9d2d6d9484131
1795616dextrose 5 % per 50 ML InjectionSYbfc4224a-2fc9-4137-b4c6-9d2d6d9484131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-9666-350033896663535 BAG in 1 CARTON (0338-9666-35) / 100 mL in 1 BAG35 bag2025-07-30NoNoCurrent