NDC 71858-0055

Tirosint

Levothyroxine Sodium

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

Product ID71858-0055_85f3c60b-7148-4e34-8ffd-603cc3e6ea34
NDC71858-0055
Product TypeHuman Prescription Drug
Proprietary NameTirosint
Generic NameLevothyroxine Sodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-09-06
Marketing CategoryNDA / NDA
Application NumberNDA021924
Labeler NameIBSA Pharma Inc.
Substance NameLEVOTHYROXINE S
Active Ingredient Strength175 ug/1
Pharm Classesl-Thyroxine [EP
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71858-0055-1

1 BLISTER PACK in 1 CARTON (71858-0055-1) > 10 CAPSULE in 1 BLISTER PACK
Marketing Start Date2018-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71858-0055-1 [71858005501]

Tirosint CAPSULE
Marketing CategoryNDA
Application NumberNDA021924
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 71858-0055-4 [71858005504]

Tirosint CAPSULE
Marketing CategoryNDA
Application NumberNDA021924
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-01

Drug Details

Active Ingredients

IngredientStrength
LEVOTHYROXINE SODIUM175 ug/1

OpenFDA Data

SPL SET ID:7a7ade79-0165-4e31-b84e-667416c00c7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905451
  • 905453
  • 905455
  • 905457
  • 905458
  • 1923052
  • 966423
  • 966420
  • 966426
  • 966405
  • 966404
  • 966407
  • 966406
  • 1923047
  • 1923050
  • 1923049
  • 905464
  • 905460
  • 905462
  • 966434
  • 966412
  • 966413
  • 966417
  • 966415

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    71858-0005TirosintTirosint
    71858-0060TirosintTirosint
    71858-0015TirosintTirosint
    71858-0040TirosintTirosint
    71858-0020TirosintTirosint
    71858-0035TirosintTirosint
    71858-0055TirosintTirosint
    71858-0025TirosintTirosint
    71858-0030TirosintTirosint
    71858-0050TirosintTirosint
    71858-0010TirosintTirosint
    71858-0045TirosintTirosint
    24090-491TirosintTirosint
    24090-493TirosintTirosint
    24090-494TirosintTirosint
    24090-495TirosintTirosint
    24090-490TirosintTirosint
    24090-492TirosintTirosint
    24090-496TirosintTirosint
    24090-497TirosintTirosint
    24090-498TirosintTirosint
    24090-499TirosintTirosint
    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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