NDC 63323-624

Dextrose

Dextrose Monohydrate

Dextrose is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Dextrose Monohydrate.

Product ID63323-624_008617d7-af80-4ecf-986b-5479b92be7a4
NDC63323-624
Product TypeHuman Prescription Drug
Proprietary NameDextrose
Generic NameDextrose Monohydrate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-10-21
Marketing CategoryANDA / ANDA
Application NumberANDA207449
Labeler NameFresenius Kabi USA, LLC
Substance NameDEXTROSE MONOHYDRATE
Active Ingredient Strength50 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-624-10

10 BAG in 1 CASE (63323-624-10) > 1000 mL in 1 BAG (63323-624-03)
Marketing Start Date2016-10-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-624-74 [63323062474]

Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207449
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-10-21

NDC 63323-624-06 [63323062406]

Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207449
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-20

NDC 63323-624-50 [63323062450]

Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207449
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-07-31

NDC 63323-624-07 [63323062407]

Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207449
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-20

NDC 63323-624-05 [63323062405]

Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207449
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-20

NDC 63323-624-61 [63323062461]

Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207449
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-10-21

NDC 63323-624-75 [63323062475]

Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207449
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-10-21

NDC 63323-624-04 [63323062404]

Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207449
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-20

NDC 63323-624-10 [63323062410]

Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207449
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-10-21

NDC 63323-624-03 [63323062403]

Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207449
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-20

Drug Details

Active Ingredients

IngredientStrength
DEXTROSE MONOHYDRATE50 mg/mL

OpenFDA Data

SPL SET ID:f2379398-a07b-417e-a022-f7b41f962067
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1795607
  • 1795610
  • 1795612
  • 1795609
  • 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

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