NDC 70518-0633

Gentak

Gentamicin Sulfate

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

Product ID70518-0633_6bd90203-4a9e-221d-e053-2991aa0a43d6
NDC70518-0633
Product TypeHuman Prescription Drug
Proprietary NameGentak
Generic NameGentamicin Sulfate
Dosage FormOintment
Route of AdministrationOPHTHALMIC
Marketing Start Date2017-07-24
Marketing CategoryANDA / ANDA
Application NumberANDA064093
Labeler NameREMEDYREPACK INC.
Substance NameGENTAMICIN SULFATE
Active Ingredient Strength3 mg/g
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-0633-0

3.5 g in 1 TUBE (70518-0633-0)
Marketing Start Date2017-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0633-0 [70518063300]

Gentak OINTMENT
Marketing CategoryANDA
Application NumberANDA064093
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-24
Marketing End Date2020-04-07

Drug Details

Active Ingredients

IngredientStrength
GENTAMICIN SULFATE3 mg/g

OpenFDA Data

SPL SET ID:db61f866-de55-42d4-870f-3f06d499b17e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 545236
  • 310466

    • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

    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
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