NDC 0168-0078

Gentamicin sulfate

Gentamicin Sulfate

Gentamicin sulfate is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Gentamicin.

Product ID0168-0078_c6dd33a2-904b-4015-8477-5018db198fdc
NDC0168-0078
Product TypeHuman Prescription Drug
Proprietary NameGentamicin sulfate
Generic NameGentamicin Sulfate
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2010-03-17
Marketing CategoryANDA / ANDA
Application NumberANDA062533
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NameGENTAMICIN
Active Ingredient Strength1 mg/g
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0168-0078-15

15 g in 1 TUBE (0168-0078-15)
Marketing Start Date2010-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0078-15 [00168007815]

Gentamicin sulfate OINTMENT
Marketing CategoryANDA
Application NumberANDA062533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GENTAMICIN1 mg/g

OpenFDA Data

SPL SET ID:f986fa2a-e667-452f-be4c-bad8588af525
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310465
  • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

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

    NDCBrand NameGeneric Name
    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
    68071-4827GENTAMICIN SULFATEGENTAMICIN SULFATE
    68071-4775Gentamicin SulfateGentamicin Sulfate
    68788-0633Gentamicin SulfateGentamicin Sulfate
    68788-6342Gentamicin SulfateGentamicin Sulfate
    68788-7336Gentamicin SulfateGentamicin Sulfate
    68788-9921GENTAMICIN SULFATEGENTAMICIN SULFATE
    70518-1323Gentamicin SulfateGentamicin Sulfate
    17478-826Gentamicin SulfateGentamicin Sulfate
    21695-187GENTAMICIN SULFATEGENTAMICIN SULFATE
    33261-604GENTAMICIN SULFATEGENTAMICIN SULFATE
    35356-707GENTAMICIN SULFATEGENTAMICIN SULFATE
    45865-672Gentamicin SulfateGentamicin Sulfate
    45802-046Gentamicin SulfateGentamicin Sulfate
    45802-056Gentamicin SulfateGentamicin Sulfate
    50090-0249Gentamicin SulfateGentamicin Sulfate
    50090-0568Gentamicin SulfateGentamicin Sulfate
    50090-0569Gentamicin SulfateGentamicin Sulfate
    50090-1883Gentamicin SulfateGentamicin Sulfate
    50436-6752Gentamicin SulfateGentamicin Sulfate
    50436-6754Gentamicin SulfateGentamicin Sulfate
    52584-207Gentamicin SulfateGentamicin Sulfate
    52565-090Gentamicin SulfateGentamicin Sulfate
    53217-229Gentamicin SulfateGentamicin Sulfate
    52959-103GENTAMICIN SULFATEGENTAMICIN SULFATE
    53002-9290Gentamicin SulfateGentamicin Sulfate
    55045-1147Gentamicin SulfateGentamicin Sulfate
    55154-2392Gentamicin SulfateGentamicin Sulfate
    60758-188GENTAMICIN SULFATEGENTAMICIN SULFATE
    61314-633Gentamicin SulfateGentamicin Sulfate
    61919-106gentamicin sulfategentamicin sulfate
    61919-918Gentamicin SulfateGentamicin Sulfate
    63187-163GENTAMICIN SULFATEGENTAMICIN SULFATE
    63187-764Gentamicin SulfateGentamicin Sulfate
    63187-560Gentamicin SulfateGentamicin Sulfate
    66267-971Gentamicin SulfateGentamicin Sulfate
    24208-580Gentamicin SulfateGentamicin Sulfate
    52565-085Gentamicin SulfateGentamicin Sulfate
    0404-9866GentamicinGentamicin 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

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