NDC 66658-105

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 ID: 66658-105_7cb59501-6411-4e31-afd0-5c9688d60e0d
• NDC: 66658-105
• Product Type: Human Prescription Drug
• Proprietary Name: Orfadin
• Generic Name: Nitisinone
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA021232
• Labeler Name: SWEDISH ORPHAN BIOVITRUM AB (PUBL)
• Substance Name: NITISINONE
• Active Ingredient Strength: 5 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: 2019-12-31

Packaging

NDC 66658-105-60

1 BOTTLE, PLASTIC in 1 CARTON (66658-105-60) > 60 CAPSULE in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2016-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66658-105-60 [66658010560]

Orfadin CAPSULE

• Marketing Category: NDA
• Application Number: NDA021232
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-01

Drug Details

Active Ingredients

Ingredient	Strength
NITISINONE	5 mg/1

OpenFDA Data

• SPL SET ID: 5d449b73-d503-4132-b978-d890491975df
• Manufacturer:
  • SWEDISH ORPHAN BIOVITRUM AB (PUBL)
• UNII:
  • K5BN214699
• 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"

NDC	Brand Name	Generic Name
66658-102	Orfadin	Nitisinone
66658-105	Orfadin	Nitisinone
66658-110	Orfadin	Nitisinone
66658-120	Orfadin	Nitisinone
66658-204	ORFADIN	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
70709-000	NITYR	Nitisinone
70709-002	NITYR	Nitisinone
70709-005	NITYR	Nitisinone