NDC 66658-204

ORFADIN

Nitisinone

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

Product ID66658-204_4a1790ec-5f28-45f5-bed4-007f281d1091
NDC66658-204
Product TypeHuman Prescription Drug
Proprietary NameORFADIN
Generic NameNitisinone
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2016-06-01
Marketing CategoryNDA / NDA
Application NumberNDA206356
Labeler NameSwedish Orphan Biovitrum AB (publ)
Substance NameNITISINONE
Active Ingredient Strength4 mg/mL
Pharm Classes4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 66658-204-90

1 BOTTLE, GLASS in 1 CARTON (66658-204-90) > 90 mL in 1 BOTTLE, GLASS
Marketing Start Date2016-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66658-204-90 [66658020490]

ORFADIN SUSPENSION
Marketing CategoryNDA
Application NumberNDA206356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-06-01

Drug Details

Active Ingredients

IngredientStrength
NITISINONE4 mg/mL

OpenFDA Data

SPL SET ID:00307f42-748d-4227-8c6f-ed5f0a89ae0a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1790317
  • 1790310

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.