NDC 21695-628

TobraDex

Tobramycin And Dexamethasone

TobraDex is a Ophthalmic Ointment in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Tobramycin; Dexamethasone.

Product ID21695-628_fe08bcd5-4d14-4c2d-940c-b7968f9a89f0
NDC21695-628
Product TypeHuman Prescription Drug
Proprietary NameTobraDex
Generic NameTobramycin And Dexamethasone
Dosage FormOintment
Route of AdministrationOPHTHALMIC
Marketing Start Date1988-09-28
Marketing CategoryNDA / NDA
Application NumberNDA050616
Labeler NameRebel Distributors Corp
Substance NameTOBRAMYCIN; DEXAMETHASONE
Active Ingredient Strength3 mg/g; mg/g
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-628-35

3.5 g in 1 TUBE (21695-628-35)
Marketing Start Date1988-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-628-35 [21695062835]

TobraDex OINTMENT
Marketing CategoryNDA
Application NumberNDA050616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1988-09-28
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
TOBRAMYCIN3 mg/g

OpenFDA Data

SPL SET ID:fe08bcd5-4d14-4c2d-940c-b7968f9a89f0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309682
  • 208821

    • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "TobraDex" or generic name "Tobramycin And Dexamethasone"

    NDCBrand NameGeneric Name
    0065-0647TobraDextobramycin and dexamethasone
    0065-0648TobraDextobramycin and dexamethasone
    0078-0876TobraDextobramycin and dexamethasone
    0078-0953TobraDextobramycin and dexamethasone
    21695-203TobraDextobramycin and dexamethasone
    21695-628TobraDextobramycin and dexamethasone
    0574-4031TOBRAMYCIN AND DEXAMETHASONEtobramycin and dexamethasone
    21695-416Tobramycin and DexamethasoneTobramycin and Dexamethasone
    24208-295Tobramycin and DexamethasoneTobramycin and Dexamethasone
    50090-1135Tobramycin and DexamethasoneTobramycin and Dexamethasone
    50090-1893Tobramycin and DexamethasoneTobramycin and Dexamethasone
    50090-1914Tobramycin and DexamethasoneTobramycin and Dexamethasone
    52959-984Tobramycin and DexamethasoneTobramycin and Dexamethasone
    55700-915Tobramycin and DexamethasoneTobramycin and Dexamethasone
    61314-647Tobramycin and DexamethasoneTobramycin and Dexamethasone
    63629-9570TOBRAMYCIN AND DEXAMETHASONEtobramycin and dexamethasone
    63629-9571TOBRAMYCIN AND DEXAMETHASONEtobramycin and dexamethasone
    63629-9572TOBRAMYCIN AND DEXAMETHASONEtobramycin and dexamethasone
    68071-1655Tobramycin and DexamethasoneTobramycin and Dexamethasone
    68071-1821Tobramycin and DexamethasoneTobramycin and Dexamethasone
    68071-2418Tobramycin and DexamethasoneTobramycin and Dexamethasone
    68071-2772TOBRAMYCIN AND DEXAMETHASONEtobramycin and dexamethasone
    68071-4203Tobramycin and DexamethasoneTobramycin and Dexamethasone

    Trademark Results [TobraDex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TOBRADEX
    TOBRADEX
    74503378 1897276 Live/Registered
    NOVARTIS AG
    1994-03-18
    TOBRADEX
    TOBRADEX
    73631951 1444831 Dead/Cancelled
    ALCON LABORATORIES, INC.
    1986-11-24
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.