NDC 66658-110

Orfadin

Nitisinone

Orfadin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Swedish Orphan Biovitrum Ab (publ). The primary component is Nitisinone.

Product ID66658-110_7cb59501-6411-4e31-afd0-5c9688d60e0d
NDC66658-110
Product TypeHuman Prescription Drug
Proprietary NameOrfadin
Generic NameNitisinone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-07-01
Marketing CategoryNDA / NDA
Application NumberNDA021232
Labeler NameSWEDISH ORPHAN BIOVITRUM AB (PUBL)
Substance NameNITISINONE
Active Ingredient Strength10 mg/1
Pharm Classes4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 66658-110-60

1 BOTTLE, PLASTIC in 1 CARTON (66658-110-60) > 60 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Start Date2016-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66658-110-60 [66658011060]

Orfadin CAPSULE
Marketing CategoryNDA
Application NumberNDA021232
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-01

Drug Details

Active Ingredients

IngredientStrength
NITISINONE10 mg/1

OpenFDA Data

SPL SET ID:5d449b73-d503-4132-b978-d890491975df
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351173
  • 351175
  • 351174
  • 352119
  • 1798999
  • 1799001
  • 352121
  • 352120

    • Pharmacological Class

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

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

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

    Trademark Results [Orfadin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ORFADIN
    ORFADIN
    75704466 2493844 Live/Registered
    Swedish Orphan International AB
    1999-05-11
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