FDA.reportPublic FDA data

Dextrose

Product NDC
70518-4219
11-digit product format
705184219
Labeler code
70518
Product ID
70518-4219_3ff7052e-e973-c6d2-e063-6294a90aa0b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE MONOHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
NDA019445
Marketing category
NDA
Marketing start
2024-10-23
Substance
DEXTROSE MONOHYDRATE
Active strength
25 g/50mL
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 MONOHYDRATE25 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G
Rxcui727517

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
70518-4219-0Dextrose10 in 1 CONTAINERINJECTION, SOLUTION104
70518-4219-0Dextrose1 in 1 CARTONINJECTION, SOLUTION14
70518-4219-1Dextrose50 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4219DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [REMEDYREPACK INC.]3Current NDC, 3 package rows20241213_b8b77421-d687-45aa-82f6-d49bce644c10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727517dextrose 50 % in 50 ML Prefilled SyringePSNb8b77421-d687-45aa-82f6-d49bce644c104
72751750 ML glucose 500 MG/ML Prefilled SyringeSCDb8b77421-d687-45aa-82f6-d49bce644c104
72751750 ML dextrose 50 % Prefilled SyringeSYb8b77421-d687-45aa-82f6-d49bce644c104
727517dextrose 25 GM per 50 ML Prefilled SyringeSYb8b77421-d687-45aa-82f6-d49bce644c104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4219-07051842190010 CARTON in 1 CONTAINER (70518-4219-0) / 1 SYRINGE, PLASTIC in 1 CARTON / 50 mL in 1 SYRINGE, PLASTIC (70518-4219-1) 10 carton2024-10-23NoNoHistorical
70518-4219-17051842190150 mL in 1 SYRINGE, PLASTIC50 mlHistorical