NDC 70709-002

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 ID: 70709-002_287a3a70-3548-4cb8-bf81-1c333aac91b1
• NDC: 70709-002
• Product Type: Human Prescription Drug
• Proprietary Name: NITYR
• Generic Name: Nitisinone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-26
• Marketing Category: NDA / NDA
• Application Number: NDA209449
• Labeler Name: Cycle Pharmaceuticals Ltd.
• Substance Name: NITISINONE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 70709-002-60

1 BOTTLE, PLASTIC in 1 CARTON (70709-002-60) > 60 TABLET in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2017-07-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70709-002-60 [70709000260]

NITYR TABLET

• Marketing Category: NDA
• Application Number: NDA209449
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-26

Drug Details

Active Ingredients

Ingredient	Strength
NITISINONE	2 mg/1

OpenFDA Data

• SPL SET ID: 00fd1905-27e4-420e-8dc5-a69e4ddc1526
• Manufacturer:
  • Cycle Pharmaceuticals Ltd.
• UNII:
  • K5BN214699
• 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"

NDC	Brand Name	Generic Name
70709-000	NITYR	Nitisinone
70709-002	NITYR	Nitisinone
70709-005	NITYR	Nitisinone
0254-3020	Nitisinone	Nitisinone
0254-3021	Nitisinone	Nitisinone
0254-3022	Nitisinone	Nitisinone
63629-2233	Nitisinone	Nitisinone
63629-2234	Nitisinone	Nitisinone
63629-2235	Nitisinone	Nitisinone
70505-202	Nitisinone	Nitisinone
70505-205	Nitisinone	Nitisinone
70505-210	Nitisinone	Nitisinone
66658-102	Orfadin	Nitisinone
66658-105	Orfadin	Nitisinone
66658-110	Orfadin	Nitisinone
66658-120	Orfadin	Nitisinone
66658-204	ORFADIN	nitisinone