NDC 0065-0643

Tobrex

Tobramycin

Tobrex is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Tobramycin.

Product ID0065-0643_0df6035f-ca2a-4dd6-adde-a4f62d0d50f1
NDC0065-0643
Product TypeHuman Prescription Drug
Proprietary NameTobrex
Generic NameTobramycin
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1981-03-15
Marketing CategoryNDA / NDA
Application NumberNDA050541
Labeler NameAlcon Laboratories, Inc.
Substance NameTOBRAMYCIN
Active Ingredient Strength3 mg/mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0065-0643-05

1 BOTTLE, PLASTIC in 1 CARTON (0065-0643-05) > 5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date1981-03-15
Marketing End Date2023-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-0643-05 [00065064305]

Tobrex SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA050541
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1981-03-15

Drug Details

Active Ingredients

IngredientStrength
TOBRAMYCIN3 mg/mL

OpenFDA Data

SPL SET ID:4b8716c4-0ffd-49aa-9006-a3bf5b6d19a6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313415
  • 207846
    • UPC Code
  • 0300650643054

    • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

    NDC Crossover Matching brand name "Tobrex" or generic name "Tobramycin"

    NDCBrand NameGeneric Name
    0065-0643Tobrextobramycin
    0065-0644TOBREXtobramycin
    0078-0813TOBREXtobramycin
    21695-458TobrexTobrex
    10122-820BETHKIStobramycin
    0078-0494TOBITobramycin
    0078-0630TOBI PodhalerTobramycin
    0093-3750TobramycinTobramycin
    0093-4085TobramycinTobramycin
    0404-7196TobramycinTobramycin
    0409-3578TOBRAMYCINTOBRAMYCIN
    0703-9402TobramycinTobramycin
    0781-7171TobramycinTobramycin
    10544-883TobramycinTobramycin
    13985-604TobramycinTobramycin
    13985-743TobramycinTobramycin
    17478-290TobramycinTobramycin
    17478-340TobramycinTobramycin

    Trademark Results [Tobrex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TOBREX
    TOBREX
    73276380 1189092 Live/Registered
    Alcon Laboratories, Inc.
    1980-09-02
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