NDC 61314-647

Tobramycin and Dexamethasone

Tobramycin And Dexamethasone

Tobramycin and Dexamethasone is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Dexamethasone; Tobramycin.

Product ID61314-647_05aa067f-40f8-4b1e-a3a8-025313a4d151
NDC61314-647
Product TypeHuman Prescription Drug
Proprietary NameTobramycin and Dexamethasone
Generic NameTobramycin And Dexamethasone
Dosage FormSuspension/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2009-01-02
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA050592
Labeler NameSandoz Inc
Substance NameDEXAMETHASONE; TOBRAMYCIN
Active Ingredient Strength1 mg/mL; mg/mL
Pharm ClassesAminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 61314-647-05

5 mL in 1 BOTTLE (61314-647-05)
Marketing Start Date2015-01-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61314-647-05 [61314064705]

Tobramycin and Dexamethasone SUSPENSION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA050592
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-01-02

NDC 61314-647-25 [61314064725]

Tobramycin and Dexamethasone SUSPENSION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA050592
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-01-02

NDC 61314-647-10 [61314064710]

Tobramycin and Dexamethasone SUSPENSION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA050592
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-01-02

Drug Details

Active Ingredients

IngredientStrength
TOBRAMYCIN3 mg/mL

OpenFDA Data

SPL SET ID:05fd0c36-39b4-4a43-8490-eb8dfc0920ae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309683
  • UPC Code
  • 0361314647054
  • Pharmacological Class

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

    Medicade Reported Pricing

    61314064725 TOBRAMYCIN-DEXAMETH OPHTH SUSP

    Pricing Unit: ML | Drug Type:

    61314064710 TOBRAMYCIN-DEXAMETH OPHTH SUSP

    Pricing Unit: ML | Drug Type:

    61314064705 TOBRAMYCIN-DEXAMETH OPHTH SUSP

    Pricing Unit: ML | Drug Type:

    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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