NDC 71858-0130

Tirosint SOL

Levothyroxine Sodium

Tirosint SOL is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Ibsa Pharma Inc.. The primary component is Levothyroxine Sodium.

Product ID71858-0130_2e777fd5-0c00-4c96-962f-d489ddf9de35
NDC71858-0130
Product TypeHuman Prescription Drug
Proprietary NameTirosint SOL
Generic NameLevothyroxine Sodium
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-03-01
Marketing CategoryNDA / NDA
Application NumberNDA206977
Labeler NameIBSA Pharma Inc.
Substance NameLEVOTHYROXINE SODIUM
Active Ingredient Strength100 ug/mL
Pharm Classesl-Thyroxine [EPC],Thyroxine [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71858-0130-1

2 POUCH in 1 CARTON (71858-0130-1) > 5 AMPULE in 1 POUCH (71858-0130-4) > 1 mL in 1 AMPULE
Marketing Start Date2019-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71858-0130-1 [71858013001]

Tirosint SOL SOLUTION
Marketing CategoryNDA
Application NumberNDA206977
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-01

NDC 71858-0130-4 [71858013004]

Tirosint SOL SOLUTION
Marketing CategoryNDA
Application NumberNDA206977
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-01

NDC 71858-0130-5 [71858013005]

Tirosint SOL SOLUTION
Marketing CategoryNDA
Application NumberNDA206977
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-01

Drug Details

Active Ingredients

IngredientStrength
LEVOTHYROXINE SODIUM100 ug/mL

OpenFDA Data

SPL SET ID:5d378add-f13d-40f2-99dc-0f2340ab44b7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2056466
  • 2056508
  • 2056462
  • 2056502
  • 2056500
  • 2056468
  • 2056506
  • 2056504
  • 2056498
  • 2056494
  • 2056496
  • 2056490
  • 2056492
  • 2056476
  • 2056474
  • 2056472
  • 2056470
  • 2056510
  • 2056478
  • 2056488
  • 2056482
  • 2056480
  • 2056486
  • 2056484

    • Pharmacological Class

    • l-Thyroxine [EPC]
    • Thyroxine [CS]

    NDC Crossover Matching brand name "Tirosint SOL" or generic name "Levothyroxine Sodium"

    NDCBrand NameGeneric Name
    71858-0115Tirosint SOLTirosint SOL
    71858-0125Tirosint SOLTirosint SOL
    71858-0140Tirosint SOLTirosint SOL
    71858-0105Tirosint SOLTirosint SOL
    71858-0130Tirosint SOLTirosint SOL
    71858-0110Tirosint SOLTirosint SOL
    71858-0145Tirosint SOLTirosint SOL
    71858-0155Tirosint SOLTirosint SOL
    71858-0150Tirosint SOLTirosint SOL
    71858-0160Tirosint SOLTirosint SOL
    71858-0120Tirosint SOLTirosint SOL
    71858-0135Tirosint SOLTirosint SOL
    0074-3727SynthroidLevothyroxine Sodium
    0074-4341SynthroidLevothyroxine Sodium
    0074-4552SynthroidLevothyroxine Sodium
    0074-5182SynthroidLevothyroxine Sodium
    0074-6594SynthroidLevothyroxine Sodium
    0074-6624SynthroidLevothyroxine Sodium
    0074-7068SynthroidLevothyroxine Sodium
    0074-7069SynthroidLevothyroxine Sodium

    Trademark Results [Tirosint]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TIROSINT
    TIROSINT
    79011405 3154257 Live/Registered
    IBSA Institut Biochimique S.A.
    2005-04-22
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