NDC 17478-284

Gentak

Gentamicin Sulfate

Gentak is a Ophthalmic Ointment in the Human Prescription Drug category. It is labeled and distributed by Akorn, Inc.. The primary component is Gentamicin Sulfate.

Product ID17478-284_073f86ba-9e02-42da-b14b-345cf5ca061b
NDC17478-284
Product TypeHuman Prescription Drug
Proprietary NameGentak
Generic NameGentamicin Sulfate
Dosage FormOintment
Route of AdministrationOPHTHALMIC
Marketing Start Date2006-05-08
Marketing CategoryANDA / ANDA
Application NumberANDA064093
Labeler NameAkorn, Inc.
Substance NameGENTAMICIN SULFATE
Active Ingredient Strength3 mg/g
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 17478-284-35

1 TUBE in 1 CARTON (17478-284-35) > 3.5 g in 1 TUBE
Marketing Start Date2006-05-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-284-35 [17478028435]

Gentak OINTMENT
Marketing CategoryANDA
Application NumberANDA064093
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2006-05-08

Drug Details

Active Ingredients

IngredientStrength
GENTAMICIN SULFATE3 mg/g

OpenFDA Data

SPL SET ID:a357d23d-1f10-44ce-a2fa-a6a5e03e7739
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 545236
  • 310466
    • UPC Code
  • 0317478284352

    • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]
    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

    Medicade Reported Pricing

    17478028435 GENTAK 0.3 % EYE OINTMENT

    Pricing Unit: GM | Drug Type:

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

    NDCBrand NameGeneric Name
    68071-1513GentakGentak
    68788-9732GentakGentak
    70518-0633GentakGentak
    17478-827GentakGentak
    17478-284GentakGentak
    49999-159GentakGentak
    50090-0251GentakGentak
    63187-873GentakGentak
    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
    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

    Trademark Results [Gentak]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GENTAK
    GENTAK
    76454682 2755775 Dead/Cancelled
    KMG ELECTRONIC CHEMICALS, INC.
    2002-10-02
    GENTAK
    GENTAK
    73652684 1464244 Live/Registered
    AKORN, INC.
    1987-04-02
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.