Infant Dextrose

Product NDC
0404-9844
11-digit product format
004049844
Labeler code
0404
Product ID
0404-9844_b6d9ad95-3f05-403d-a0c1-a7ff81d9351b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
NDA019445
Marketing category
NDA
Marketing start
2022-01-10
Substance
DEXTROSE MONOHYDRATE
Active strength
250 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE250 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G
Rxcui727518

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
0404-9844-10Infant Dextrose10 mL in 1 SYRINGEINJECTION, SOLUTION107
0404-9844-10Infant Dextrose1 in 1 BAGINJECTION, SOLUTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9844INFANT DEXTROSE (DEXTROSE ) INJECTION, SOLUTION [HENRY SCHEIN, INC.]6Current NDC, Legacy NDC, 2 package rows20240518_ce71d929-d11e-444c-bd45-e025d5172057.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727518dextrose 25 % in 10 ML Prefilled SyringePSNce71d929-d11e-444c-bd45-e025d51720577
72751810 ML glucose 250 MG/ML Prefilled SyringeSCDce71d929-d11e-444c-bd45-e025d51720577
72751810 ML dextrose 25 % Prefilled SyringeSYce71d929-d11e-444c-bd45-e025d51720577
727518dextrose 2.5 GM per 10 ML Prefilled SyringeSYce71d929-d11e-444c-bd45-e025d51720577
727518dextrose 2500 MG per 10 ML Prefilled SyringeSYce71d929-d11e-444c-bd45-e025d51720577

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9844-10004049844101 SYRINGE in 1 BAG (0404-9844-10) / 10 mL in 1 SYRINGE1 syringe2022-01-100000-00-00NoNoCurrent