NDC 70954-009

Nitisinone

Nitisinone

Nitisinone is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novitium Pharma Llc. The primary component is Nitisinone.

Product ID70954-009_76da5c07-0bd8-4f69-8e71-9d72ce2dc92f
NDC70954-009
Product TypeHuman Prescription Drug
Proprietary NameNitisinone
Generic NameNitisinone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA211041
Labeler NameNovitium Pharma LLC
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 Through2020-12-31

Packaging

NDC 70954-009-20

60 CARTON in 1 BOTTLE (70954-009-20) > 1 CAPSULE in 1 CARTON
Marketing Start Date2019-08-26
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
NITISINONE5 mg/1

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

NDCBrand NameGeneric Name
0254-3020NitisinoneNitisinone
0254-3021NitisinoneNitisinone
0254-3022NitisinoneNitisinone
63629-2233NitisinoneNitisinone
63629-2234NitisinoneNitisinone
63629-2235NitisinoneNitisinone
70505-202NitisinoneNitisinone
70505-205NitisinoneNitisinone
70505-210NitisinoneNitisinone
70954-010NitisinoneNitisinone
70954-008NitisinoneNitisinone
70954-009NitisinoneNitisinone
70709-000NITYRNitisinone
70709-002NITYRNitisinone
70709-005NITYRNitisinone
66658-102OrfadinNitisinone
66658-105OrfadinNitisinone
66658-110OrfadinNitisinone
66658-120OrfadinNitisinone
66658-204ORFADINnitisinone

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