NDC 70709-005

NITYR

Nitisinone

NITYR is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Cycle Pharmaceuticals Ltd.. The primary component is Nitisinone.

Product ID70709-005_287a3a70-3548-4cb8-bf81-1c333aac91b1
NDC70709-005
Product TypeHuman Prescription Drug
Proprietary NameNITYR
Generic NameNitisinone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-07-26
Marketing CategoryNDA / NDA
Application NumberNDA209449
Labeler NameCycle Pharmaceuticals Ltd.
Substance NameNITISINONE
Active Ingredient Strength5 mg/1
Pharm Classes4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70709-005-60

1 BOTTLE, PLASTIC in 1 CARTON (70709-005-60) > 60 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date2017-07-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70709-005-60 [70709000560]

NITYR TABLET
Marketing CategoryNDA
Application NumberNDA209449
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-26

Drug Details

Active Ingredients

IngredientStrength
NITISINONE5 mg/1

OpenFDA Data

SPL SET ID:00fd1905-27e4-420e-8dc5-a69e4ddc1526
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1941473
  • 1941471
  • 1941470
  • 1941464
  • 1941476
  • 1941474
    • UPC Code
  • 0370709002606
  • 0370709000602
  • 0370709005607

    • Pharmacological Class

    • 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC]
    • Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA]
    • Cytochrome P450 2C9 Inhibitors [MoA]

    NDC Crossover Matching brand name "NITYR" or generic name "Nitisinone"

    NDCBrand NameGeneric Name
    70709-000NITYRNitisinone
    70709-002NITYRNitisinone
    70709-005NITYRNitisinone
    0254-3020NitisinoneNitisinone
    0254-3021NitisinoneNitisinone
    0254-3022NitisinoneNitisinone
    63629-2233NitisinoneNitisinone
    63629-2234NitisinoneNitisinone
    63629-2235NitisinoneNitisinone
    70505-202NitisinoneNitisinone
    70505-205NitisinoneNitisinone
    70505-210NitisinoneNitisinone
    66658-102OrfadinNitisinone
    66658-105OrfadinNitisinone
    66658-110OrfadinNitisinone
    66658-120OrfadinNitisinone
    66658-204ORFADINnitisinone

    Trademark Results [NITYR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NITYR
    NITYR
    87604011 5716643 Live/Registered
    Cycle Pharmaceuticals Ltd.
    2017-09-11
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