FDA.reportPublic FDA data

Dextrose

Product NDC
0409-1775
11-digit product format
004091775
Labeler code
0409
Product ID
0409-1775_5d7b785b-49b6-4bb6-b8c6-97c882613668
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextrose monohydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA019445
Marketing category
NDA
Marketing start
2006-02-22
Substance
DEXTROSE MONOHYDRATE
Active strength
250 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 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
0409-1775-10Dextrose10 in 1 PACKAGEINJECTION, SOLUTION1025
0409-1775-10Dextrose1 in 1 CARTONINJECTION, SOLUTION125
0409-1775-40Dextrose10 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION1025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1775-10ML - Milliliter0409-177550b354b9-196e-41d0-9fd0-a88febcd4f1f12012-07-24
0409-1775-40ML - Milliliter0409-1775c65f3521-2484-47ce-802c-cf3593d63b5b12020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]10
DEXTROSEACTIVE MOIETYIY9XDZ35W2DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]10
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]10
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]10
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1775DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]23Current NDC, Legacy NDC, 3 package rows20241031_672264e3-9709-4bba-2a9d-12bf70c7396a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727518dextrose 25 % in 10 ML Prefilled SyringePSN672264e3-9709-4bba-2a9d-12bf70c7396a25
72751810 ML glucose 250 MG/ML Prefilled SyringeSCD672264e3-9709-4bba-2a9d-12bf70c7396a25
72751810 ML dextrose 25 % Prefilled SyringeSY672264e3-9709-4bba-2a9d-12bf70c7396a25
727518dextrose 2.5 GM per 10 ML Prefilled SyringeSY672264e3-9709-4bba-2a9d-12bf70c7396a25
727518dextrose 2500 MG per 10 ML Prefilled SyringeSY672264e3-9709-4bba-2a9d-12bf70c7396a25
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
727518dextrose 25 % in 10 ML Prefilled SyringePSN73d04839-a2bb-65dd-e053-2991aa0a82ca6
72751810 ML glucose 250 MG/ML Prefilled SyringeSCD73d04839-a2bb-65dd-e053-2991aa0a82ca6
72751810 ML dextrose 25 % Prefilled SyringeSY73d04839-a2bb-65dd-e053-2991aa0a82ca6
727518dextrose 2.5 GM per 10 ML Prefilled SyringeSY73d04839-a2bb-65dd-e053-2991aa0a82ca6
727518dextrose 2500 MG per 10 ML Prefilled SyringeSY73d04839-a2bb-65dd-e053-2991aa0a82ca6
727518dextrose 25 % in 10 ML Prefilled SyringePSNada63d44-3b37-b65d-e053-2a95a90aa0882
72751810 ML glucose 250 MG/ML Prefilled SyringeSCDada63d44-3b37-b65d-e053-2a95a90aa0882
72751810 ML dextrose 25 % Prefilled SyringeSYada63d44-3b37-b65d-e053-2a95a90aa0882
727518dextrose 2.5 GM per 10 ML Prefilled SyringeSYada63d44-3b37-b65d-e053-2a95a90aa0882
727518dextrose 2500 MG per 10 ML Prefilled SyringeSYada63d44-3b37-b65d-e053-2a95a90aa0882
727518dextrose 25 % in 10 ML Prefilled SyringePSNe2638b45-1141-4391-971d-c0dea825e41c1
72751810 ML glucose 250 MG/ML Prefilled SyringeSCDe2638b45-1141-4391-971d-c0dea825e41c1
72751810 ML dextrose 25 % Prefilled SyringeSYe2638b45-1141-4391-971d-c0dea825e41c1
727518dextrose 2.5 GM per 10 ML Prefilled SyringeSYe2638b45-1141-4391-971d-c0dea825e41c1
727518dextrose 2500 MG per 10 ML Prefilled SyringeSYe2638b45-1141-4391-971d-c0dea825e41c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1775-100040917751010 CARTON in 1 PACKAGE (0409-1775-10) / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC (0409-1775-40) 10 carton2006-02-220000-00-00NoNoCurrent
0409-1775-400040917754010 mL in 1 SYRINGE, PLASTIC10 mlHistorical