Dextrose

Product NDC
0990-7938
11-digit product format
009907938
Labeler code
0990
Product ID
0990-7938_43f81a41-0a45-45f5-840c-768d768edd3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextrose monohydrate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
ICU Medical, Inc.
Application
NDA018080
Marketing category
NDA
Marketing start
2019-11-20
Substance
DEXTROSE MONOHYDRATE
Active strength
10 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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G
Rxcui1795477

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
0990-7938-19Dextrose1 in 1 POUCHINJECTION, SOLUTION, CONCENTRATE115
0990-7938-19Dextrose12 in 1 CASEINJECTION, SOLUTION, CONCENTRATE1215

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7938-19ML - Milliliter0990-7938b33fcc75-b3d8-482d-8b8c-ca03b174018012021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7938DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION, CONCENTRATE [ICU MEDICAL INC.]9Current NDC, Legacy NDC, 2 package rows20240711_cb578dba-094c-4787-951d-763d12fd06e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795477dextrose 10 % in 500 ML InjectionPSNcb578dba-094c-4787-951d-763d12fd06e115
1795477500 ML glucose 100 MG/ML InjectionSCDcb578dba-094c-4787-951d-763d12fd06e115
1795477dextrose 10 % per 500 ML InjectionSYcb578dba-094c-4787-951d-763d12fd06e115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7938-190099079381912 POUCH in 1 CASE (0990-7938-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG12 pouch2019-11-200000-00-00NoNoCurrent