NDC 0409-1029

Voluven

Hydroxyethyl Starch 130/0.4

Voluven is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira Inc.. The primary component is Hydroxyethyl Starch 130/0.4.

Product ID0409-1029_4cf79958-bba6-4ab0-b970-92b80ce04439
NDC0409-1029
Product TypeHuman Prescription Drug
Proprietary NameVoluven
Generic NameHydroxyethyl Starch 130/0.4
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-06-25
Marketing CategoryNDA / NDA
Application NumberBN070012
Labeler NameHospira Inc.
Substance NameHYDROXYETHYL STARCH 130/0.4
Active Ingredient Strength6 g/100mL
Pharm ClassesPlasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0409-1029-01

15 BAG in 1 CARTON (0409-1029-01) > 500 mL in 1 BAG (0409-1029-11)
Marketing Start Date2010-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-1029-11 [00409102911]

Voluven INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberBN070012
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-11-07
Marketing End Date2020-02-28

NDC 0409-1029-01 [00409102901]

Voluven INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberBN070012
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-06-25
Marketing End Date2020-02-28

NDC 0409-1029-02 [00409102902]

Voluven INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberBN070012
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-03-15
Marketing End Date2020-02-28

Drug Details

Active Ingredients

IngredientStrength
HYDROXYETHYL STARCH 130/0.46 g/100mL

OpenFDA Data

SPL SET ID:c2c45e02-5d9a-4a54-f291-e5b54671b08b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1363394
  • 1855393

    • Pharmacological Class

    • Plasma Volume Expander [EPC]
    • Increased Intravascular Volume [PE]
    • Osmotic Activity [MoA]
    • Starch [CS]

    Trademark Results [Voluven]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VOLUVEN
    VOLUVEN
    75921641 2497816 Live/Registered
    FRESENIUS SE & CO. KGAA
    2000-02-16
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