NDC 70505-205

Nitisinone

Nitisinone

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

Product ID70505-205_6f0fe86a-1c6f-4d95-9355-6bf558cbcaa8
NDC70505-205
Product TypeHuman Prescription Drug
Proprietary NameNitisinone
Generic NameNitisinone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-06-15
Marketing CategoryANDA /
Application NumberANDA212390
Labeler NameAnalog Pharma
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 70505-205-60

1 BOTTLE, PLASTIC in 1 CARTON (70505-205-60) > 60 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Start Date2022-06-15
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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