NDC 70594-044

Vancomycin

Vancomycin

Vancomycin is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Xellia Pharmaceuticals Usa Llc. The primary component is Vancomycin.

Product ID70594-044_6509eb92-c2d2-4d5d-bd52-5878f837eb24
NDC70594-044
Product TypeHuman Prescription Drug
Proprietary NameVancomycin
Generic NameVancomycin
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-02-15
Marketing CategoryNDA / NDA
Application NumberNDA211962
Labeler NameXellia Pharmaceuticals USA LLC
Substance NameVANCOMYCIN
Active Ingredient Strength2 g/400mL
Pharm ClassesGlycopeptide Antibacterial [EPC],Glycopeptides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70594-044-02

6 BAG in 1 CARTON (70594-044-02) > 400 mL in 1 BAG (70594-044-01)
Marketing Start Date2019-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70594-044-02 [70594004402]

Vancomycin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA211962
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-02-15

NDC 70594-044-01 [70594004401]

Vancomycin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA211962
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-02-15

Drug Details

Active Ingredients

IngredientStrength
VANCOMYCIN2 g/400mL

OpenFDA Data

SPL SET ID:60bee69b-be70-412c-9e83-a24a0a8a5e7b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1807511
  • 2118449
  • 2118448
  • 1807508
  • Pharmacological Class

    • Glycopeptide Antibacterial [EPC]
    • Glycopeptides [CS]
    • Glycopeptide Antibacterial [EPC]
    • Glycopeptides [CS]

    NDC Crossover Matching brand name "Vancomycin" or generic name "Vancomycin"

    NDCBrand NameGeneric Name
    25021-157Vancomycinvancomycin hydrochloride
    25021-158Vancomycinvancomycin hydrochloride
    70594-040VancomycinVancomycin
    70594-041VancomycinVancomycin
    70594-042VancomycinVancomycin
    70594-043VancomycinVancomycin
    70594-044VancomycinVancomycin
    70594-056VancomycinVancomycin
    70594-057VancomycinVancomycin
    70594-058VancomycinVancomycin
    51991-940Vancomycin HydrochlorideVancomycin
    51991-941Vancomycin HydrochlorideVancomycin
    68001-338Vancomycin HydrochlorideVancomycin
    68001-339Vancomycin HydrochlorideVancomycin

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