NDC 0338-0503

Gentamicin Sulfate in Sodium Chloride

Gentamicin Sulfate

Gentamicin Sulfate in Sodium Chloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Gentamicin Sulfate.

Product ID0338-0503_0a39a418-42e2-4060-88ea-33b0b19f7a47
NDC0338-0503
Product TypeHuman Prescription Drug
Proprietary NameGentamicin Sulfate in Sodium Chloride
Generic NameGentamicin Sulfate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1982-09-07
Marketing CategoryANDA / ANDA
Application NumberANDA062373
Labeler NameBaxter Healthcare Corporation
Substance NameGENTAMICIN SULFATE
Active Ingredient Strength80 mg/100mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0338-0503-48

100 mL in 1 BAG (0338-0503-48)
Marketing Start Date1982-09-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0338-0503-48 [00338050348]

Gentamicin Sulfate in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062373
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1982-09-07

NDC 0338-0503-41 [00338050341]

Gentamicin Sulfate in Sodium Chloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA062373
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1982-09-07
Marketing End Date2009-06-30

Drug Details

Active Ingredients

IngredientStrength
GENTAMICIN SULFATE80 mg/100mL

OpenFDA Data

SPL SET ID:449c9a41-d61e-49fd-b5e3-d76f74b92acf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242816
  • 310477
  • 310473
  • 1870633
  • 1870631
  • 197736

    • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

    NDC Crossover Matching brand name "Gentamicin Sulfate in Sodium Chloride" or generic name "Gentamicin Sulfate"

    NDCBrand NameGeneric Name
    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
    0404-9866GentamicinGentamicin Sulfate
    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
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