NDC 63629-2235

Nitisinone

Nitisinone

Nitisinone is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Nitisinone.

Product ID63629-2235_19459a67-3c72-45b7-8d46-c4c3a88e6ebd
NDC63629-2235
Product TypeHuman Prescription Drug
Proprietary NameNitisinone
Generic NameNitisinone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-10-04
Marketing CategoryANDA /
Application NumberANDA211041
Labeler NameBryant Ranch Prepack
Substance NameNITISINONE
Active Ingredient Strength5 mg/1
Pharm Classes4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2E1 Inducers [MoA], Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63629-2235-1

1 BOTTLE in 1 CARTON (63629-2235-1) > 60 CAPSULE in 1 BOTTLE
Marketing Start Date2021-03-22
NDC Exclude FlagN
Sample Package?N

Drug Details

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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