NDC 0254-3021

Nitisinone

Nitisinone

Nitisinone is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Nitisinone.

Product ID0254-3021_75548bb0-fbf1-4ac5-86af-cd6dc30de589
NDC0254-3021
Product TypeHuman Prescription Drug
Proprietary NameNitisinone
Generic NameNitisinone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-10-04
Marketing CategoryANDA / ANDA
Application NumberANDA211041
Labeler NamePar Pharmaceutical, Inc.
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 0254-3021-02

1 BOTTLE in 1 CARTON (0254-3021-02) > 60 CAPSULE in 1 BOTTLE
Marketing Start Date2019-10-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0254-3021-20 [00254302120]

Nitisinone CAPSULE
Marketing CategoryANDA
Application NumberANDA211041
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Marketing End Date2019-10-29

NDC 0254-3021-02 [00254302102]

Nitisinone CAPSULE
Marketing CategoryANDA
Application NumberANDA211041
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-04

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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