NDC 0264-1968

Hydroxyethyl Starch in Sodium Chloride

Hydroxyethyl Starch In Sodium Chloride

Hydroxyethyl Starch in Sodium Chloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by B. Braun Medical Inc.. The primary component is Hydroxyethyl Starch 130/0.4; Sodium Chloride.

Product ID0264-1968_79f3c629-3cc6-4ee7-82e8-6ca0d5ba1f4c
NDC0264-1968
Product TypeHuman Prescription Drug
Proprietary NameHydroxyethyl Starch in Sodium Chloride
Generic NameHydroxyethyl Starch In Sodium Chloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-01-09
Marketing CategoryANDA / ANDA
Application NumberANDA110013
Labeler NameB. Braun Medical Inc.
Substance NameHYDROXYETHYL STARCH 130/0.4; SODIUM CHLORIDE
Active Ingredient Strength6 g/100mL; mg/100mL
Pharm ClassesPlasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0264-1968-10

12 CONTAINER in 1 CASE (0264-1968-10) > 500 mL in 1 CONTAINER
Marketing Start Date2015-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0264-1968-10 [00264196810]

Hydroxyethyl Starch in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA110013
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-09
Inactivation Date2020-01-31
Reactivation Date2020-03-10

Drug Details

Active Ingredients

IngredientStrength
HYDROXYETHYL STARCH 130/0.46 g/100mL

OpenFDA Data

SPL SET ID:be7729c9-f7cf-483b-bafe-0d42d6b62f06
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1855393
  • Pharmacological Class

    • Plasma Volume Expander [EPC]
    • Increased Intravascular Volume [PE]
    • Osmotic Activity [MoA]
    • Starch [CS]
    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]

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