Label: DEXTROSE- dextrose monohydrate injection, solution

  • NDC Code(s): 0338-9588-01, 0338-9588-12, 0338-9830-01, 0338-9830-03
  • Packager: Baxter Healthcare Company
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 6, 2024

If you are a consumer or patient please visit this version.

  • Health Care Provider Letter

    DHCP Letter 1 of 17
    DHCP Letter 2 of 17
    DHCP Letter 3 of 17
    DHCP Letter 4 of 17
    DHCP Letter 5 of 17
    DHCP Letter 6 of 17
    DHCP Letter 7 of 17
    DHCP Letter 8 of 17
    DHCP Letter 9 of 17
    DHCP Letter 10 of 17
    DHCP Letter 11 of 17
    DHCP Letter 12 of 17
    DHCP Letter 13 of 17
    DHCP Letter 14 of 17
    DHCP Letter 15 of 17
    DHCP Letter 16 of 17
    DHCP Letter 17 of 17
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Container Label NDC 0338-9830-01

    Container Label

    JB0062 250 mL DIN 00060348

    5% Dextrose Injection USP

    Dextrose à 5% USP, Injectable

    D5W

    2D Barcode
    (01)00809080000258

    APPROX mOsmol/L – 252
    pH 4.0

    INTRAVENOUS FLUID AND NUTRI-
    ENT REPLENISHIMENT / RECHARGE
    LIQUIDIENNE ET NUTRIMENT PAR
    INJECTION INTRAVEINEUSE

    PER 100 mL DEXTROSE HYDROUS
    USP – 5 g / WATER FOR INJECTION
    USP – qs / pH MAY BE ADJUSTED
    WITH SODIUM HYDROXIDE

    PAR 100 mL DEXTROSE HYDRATE USP – 5 g / EAU POUR
    INJECTION USP – qs / pH PEUT ETRE AJUSTE AVEC DE
    L’HYDROXYDE DE SODIUM

    CAUTIONS SINGLE USE / DISCARD UNUSED PORTION
    / SQUEEZE AND INSPECT BAG / SEE DIRECTIONS FOR
    USE / MUST NOT BE USED IN SERIES CONNECTIONS /
    DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD /
    STORE AT 15°C TO 25°C

    ATTENTIONS USAGE UNIQUE / JETER PORTION INTUI-
    LISEE / PRESSER ET INSPECTOR LE SAC / VOIR MODE
    D’EMPLOI / NE DOIT PAS ETRE MONTE EN SERIE / NE PAS
    ADMINISTRER SIMULTANEMENT AVEC LA SANG / GARDER
    ENTRE 15°C ET 25°C

    NONPYROGENIC / STERILE / APYROGENE

    VIAFLEX® PVC CONTAINER / CONTENANT DE PVC

    Baxter Logo
    Baxter Corporation
    Mississauga ON L5N 0C2

    No Latex Label

    88-70-20-465

    50

    100

    150

    200

    Container Label NDC 0338-9588-01

    Container Label

    JB0064 1000 mL DIN 00060348

    5% Dextrose
    Injection USP

    Dextrose à 5%
    USP, Injectable

    D5W

    APPROX mOsmol/L – 252 pH 4.0

    INTRAVENOUS FLUID AND NUTRIENT REPLENISHIMENT /
    RECHARGE LIQUIDIENNE ET NUTRIMENT PAR INJECTION
    INTRAVEINEUSE

    PER 100 mL DEXTROSE HYDROUS USP – 5 g / WATER FOR
    INJECTION USP – qs / pH MAY BE ADJUSTED WITH SODIUM
    HYDROXIDE

    PAR 100 mL DEXTROSE HYDRATE USP – 5 g / EAU POUR
    INJECTION USP – qs / pH PEUT ETRE AJUSTE AVEC DE
    L’HYDROXYDE DE SODIUM

    CAUTIONS SINGLE USE / DISCARD UNUSED PORTION
    SQUEEZE AND INSPECT BAG / SEE DIRECTIONS FOR USE
    MUST NOT BE USED IN SERIES CONNECTIONS / DO NOT
    ADMINISTER SIMULTANEOUSLY WITH BLOOD / STORE AT
    15°C TO 25°C

    ATTENTIONS USAGE UNIQUE / JETER PORTION INTUILISEE
    PRESSER ET INSPECTOR LE SAC / VOIR MODE D’EMPLOI NE
    DOIT PAS ETRE MONTE EN SERIE / NE PAS ADMINISTRER
    SIMULTANEMENT AVEC LA SANG / GARDER ENTRE 15°C
    ET 25°C

    NONPYROGENIC / STERILE / APYROGENE

    VIAFLEX PVC CONTAINER / CONTENANT DE PVC

    BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC
    BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER
    INTERNATIONAL INC

    Baxter Logo
    Baxter Corporation
    Mississauga ON L5N 0C2

    No Latex Label

    07-25-77-316

    1

    _

    2

    _

    3

    _

    4

    _

    5

    _

    6

    _

    7

    _

    8

    _

    9

  • INGREDIENTS AND APPEARANCE
    DEXTROSE 
    dextrose monohydrate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9830
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE50 g  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9830-0330 in 1 CARTON11/06/2024
    1NDC:0338-9830-01250 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage11/06/2024
    DEXTROSE 
    dextrose monohydrate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9588
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE50 g  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9588-1212 in 1 CARTON11/06/2024
    1NDC:0338-9588-011000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage11/06/2024
    Labeler - Baxter Healthcare Company (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Corporation205087968ANALYSIS(0338-9830, 0338-9588) , LABEL(0338-9830, 0338-9588) , MANUFACTURE(0338-9830, 0338-9588) , STERILIZE(0338-9830, 0338-9588) , PACK(0338-9830, 0338-9588)