NDC 63323-010

Gentamicin

Gentamicin Sulfate

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

Product ID63323-010_2bd31356-d9aa-4706-b0bd-ec505a3c5413
NDC63323-010
Product TypeHuman Prescription Drug
Proprietary NameGentamicin
Generic NameGentamicin Sulfate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2000-08-10
Marketing CategoryANDA / ANDA
Application NumberANDA062366
Labeler NameFresenius Kabi USA, LLC
Substance NameGENTAMICIN SULFATE
Active Ingredient Strength40 mg/mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63323-010-02

25 VIAL in 1 TRAY (63323-010-02) > 2 mL in 1 VIAL (63323-010-01)
Marketing Start Date2000-08-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-010-02 [63323001002]

Gentamicin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-08-10

NDC 63323-010-94 [63323001094]

Gentamicin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-08-10

NDC 63323-010-96 [63323001096]

Gentamicin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-08-10

NDC 63323-010-95 [63323001095]

Gentamicin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-08-10

NDC 63323-010-20 [63323001020]

Gentamicin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-08-10

Drug Details

Active Ingredients

IngredientStrength
GENTAMICIN SULFATE40 mg/mL

OpenFDA Data

SPL SET ID:0cce2238-28d3-4280-b520-ffc3067a2ffa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313996

    • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

    Medicade Reported Pricing

    63323001094 GENTAMICIN 80 MG/2 ML VIAL

    Pricing Unit: ML | Drug Type:

    63323001020 GENTAMICIN 40 MG/ML VIAL

    Pricing Unit: ML | Drug Type:

    63323001002 GENTAMICIN 80 MG/2 ML VIAL

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Gentamicin" or generic name "Gentamicin Sulfate"

    NDCBrand NameGeneric Name
    0143-9128GentamicinGentamicin
    0143-9129GentamicinGentamicin
    0404-9866GentamicinGentamicin Sulfate
    52584-010GentamicinGentamicin
    63323-010GentamicinGentamicin
    63323-173GentamicinGentamicin
    0168-0071Gentamicin Sulfategentamicin sulfate
    0168-0078Gentamicin sulfateGentamicin Sulfate
    0404-9865Gentamicin SulfateGentamicin Sulfate
    0409-1207Gentamicin SulfateGENTAMICIN SULFATE
    0713-0682Gentamicin SulfateGentamicin Sulfate
    0713-0683Gentamicin SulfateGentamicin Sulfate
    13985-603Gentamicin SulfateGentamicin Sulfate
    17478-283Gentamicin SulfateGentamicin Sulfate
    0338-0503Gentamicin Sulfate in Sodium ChlorideGentamicin Sulfate
    0338-0505Gentamicin Sulfate in Sodium ChlorideGentamicin Sulfate
    0338-0507Gentamicin Sulfate in Sodium ChlorideGentamicin Sulfate
    0338-0509Gentamicin Sulfate in Sodium ChlorideGentamicin Sulfate
    0338-0511Gentamicin Sulfate in Sodium ChlorideGentamicin Sulfate
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.