NDC 52584-010

Gentamicin

Gentamicin Sulfate

Gentamicin is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Gentamicin Sulfate.

Product ID52584-010_298b88b9-c827-4f5d-971a-1a92b4a493b4
NDC52584-010
Product TypeHuman Prescription Drug
Proprietary NameGentamicin
Generic NameGentamicin Sulfate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2010-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA062366
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameGENTAMICIN SULFATE
Active Ingredient Strength40 mg/mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-010-20

1 VIAL, MULTI-DOSE in 1 BAG (52584-010-20) > 20 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2010-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-010-20 [52584001020]

Gentamicin INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062366
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-01

Drug Details

Active Ingredients

IngredientStrength
GENTAMICIN SULFATE40 mg/mL

OpenFDA Data

SPL SET ID:8104ee83-6e67-4e61-8cb2-854fc72cd87d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313996

    • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

    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
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