NDC 52959-984

Tobramycin and Dexamethasone

Tobramycin And Dexamethasone

Tobramycin and Dexamethasone is a Ophthalmic Suspension in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Tobramycin; Dexamethasone.

Product ID52959-984_fb0e30f7-a594-40cf-b56c-a45cfbcd60d8
NDC52959-984
Product TypeHuman Prescription Drug
Proprietary NameTobramycin and Dexamethasone
Generic NameTobramycin And Dexamethasone
Dosage FormSuspension
Route of AdministrationOPHTHALMIC
Marketing Start Date2009-01-02
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA050592
Labeler NameH.J. Harkins Company, Inc.
Substance NameTOBRAMYCIN; DEXAMETHASONE
Active Ingredient Strength3 mg/mL; mg/mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52959-984-05

5 mL in 1 BOTTLE (52959-984-05)
Marketing Start Date2009-01-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-984-10 [52959098410]

Tobramycin and Dexamethasone SUSPENSION
Marketing CategoryNDA authorized generic
Application NumberNDA050592
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-01-02
Inactivation Date2019-11-13

NDC 52959-984-05 [52959098405]

Tobramycin and Dexamethasone SUSPENSION
Marketing CategoryNDA authorized generic
Application NumberNDA050592
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-02
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
TOBRAMYCIN3 mg/mL

OpenFDA Data

SPL SET ID:8f7f1b78-8ac3-4ba5-b0ec-ca87a433ad39
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309683

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68788-9342Tobramycin and DexamethasoneTobramycin and Dexamethasone
    0065-0647TobraDextobramycin and dexamethasone
    0065-0648TobraDextobramycin and dexamethasone
    0078-0876TobraDextobramycin and dexamethasone
    0078-0953TobraDextobramycin and dexamethasone
    21695-203TobraDextobramycin and dexamethasone
    21695-628TobraDextobramycin and dexamethasone
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