NDC 52584-517

Dextrose

Dextrose Monohydrate

Dextrose is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Dextrose Monohydrate.

Product ID52584-517_5316141c-f8d0-419a-aaa9-67244dfc5f7c
NDC52584-517
Product TypeHuman Prescription Drug
Proprietary NameDextrose
Generic NameDextrose Monohydrate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-07-01
Marketing End Date2024-03-01
Marketing CategoryNDA / NDA
Application NumberNDA019445
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameDEXTROSE MONOHYDRATE
Active Ingredient Strength25 g/50mL
NDC Exclude FlagN

Packaging

NDC 52584-517-16

1 SYRINGE in 1 BAG (52584-517-16) > 50 mL in 1 SYRINGE
Marketing Start Date2010-07-01
Marketing End Date2024-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-517-16 [52584051716]

Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019445
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-07-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROSE MONOHYDRATE25 g/50mL

OpenFDA Data

SPL SET ID:8a021339-bebf-4001-993a-f163518e04b8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 727517
  • NDC Crossover Matching brand name "Dextrose" or generic name "Dextrose Monohydrate"

    NDCBrand NameGeneric Name
    0264-1290DextroseDEXTROSE
    0264-1510DextroseDextrose
    0264-7387DextroseDextrose
    0264-7510DEXTROSEDEXTROSE
    0264-7520DEXTROSEDEXTROSE
    0338-0017DEXTROSEDEXTROSE MONOHYDRATE
    0338-0023DEXTROSEDEXTROSE MONOHYDRATE
    0338-0062DEXTROSEdextrose monohydrate
    0338-0066DEXTROSEdextrose monohydrate
    0338-0070DEXTROSEdextrose monohydrate
    0338-0074DEXTROSEdextrose monohydrate
    0409-4902DextroseDextrose
    0409-6648DextroseDextrose
    0409-7120DextroseDextrose
    0409-7100DextroseDextrose
    0409-7922DextroseDextrose
    0409-7923DextroseDextrose
    0409-7517DextroseDextrose
    0409-7918DextroseDextrose
    0409-7935DextroseDextrose
    0409-7930DextroseDextrose
    0409-7936DextroseDextrose
    0409-7937DextroseDextrose
    0409-7938DextroseDextrose
    0409-8004DextroseDextrose
    70518-1427DextroseDextrose
    71872-7003DextroseDextrose
    71872-7057DextroseDextrose
    71872-7102DextroseDextrose
    17271-720DextroseDextrose
    50090-1889DextroseDextrose
    51662-1214DEXTROSEDEXTROSE
    51662-1215DEXTROSEDEXTROSE
    51662-1306DEXTROSEDEXTROSE
    52584-517DextroseDextrose
    52584-648DextroseDextrose
    52584-902DextroseDextrose
    55154-2886DEXTROSEDEXTROSE
    55154-2887DEXTROSEDEXTROSE
    55154-2885DEXTROSEDEXTROSE
    55154-6977DextroseDextrose
    0338-0078DEXTROSEDEXTROSE
    0338-0082DEXTROSEDEXTROSE
    0338-0719DEXTROSEDEXTROSE
    0338-9147DextroseDextrose
    0338-0551DextroseDextrose
    0338-9533DextroseDextrose

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.