NDC 63323-173

Gentamicin

Gentamicin

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 ID63323-173_4a9149ef-4409-482b-bd5e-f52a9fd1469a
NDC63323-173
Product TypeHuman Prescription Drug
Proprietary NameGentamicin
Generic NameGentamicin
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2004-11-29
Marketing CategoryANDA / ANDA
Application NumberANDA062366
Labeler NameFresenius Kabi USA, LLC
Substance NameGENTAMICIN SULFATE
Active Ingredient Strength10 mg/mL
Pharm ClassesAminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 63323-173-02

25 VIAL in 1 TRAY (63323-173-02) > 2 mL in 1 VIAL (63323-173-01)
Marketing Start Date2004-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-173-02 [63323017302]

Gentamicin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-11-29

NDC 63323-173-94 [63323017394]

Gentamicin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-11-29

NDC 63323-173-95 [63323017395]

Gentamicin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-11-29

Drug Details

Active Ingredients

IngredientStrength
GENTAMICIN SULFATE10 mg/mL

OpenFDA Data

SPL SET ID:63413469-c676-48a3-a945-7d2489b535ef
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1870676
  • UPC Code
  • 0363323173951
  • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

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

    NDCBrand NameGeneric Name
    0143-9128GentamicinGentamicin
    0143-9129GentamicinGentamicin
    0404-9866GentamicinGentamicin Sulfate
    51662-1508GENTAMICINGENTAMICIN
    52584-010GentamicinGentamicin Sulfate
    63323-010GentamicinGENTAMICIN SULFATE
    63323-173GentamicinGENTAMICIN

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