NDC product

Nitisinone

NDC 0254-3020 · Par Health USA, LLC

Key facts

Product NDC 0254-3020
Proprietary name Nitisinone
Nonproprietary name Nitisinone
Substances NITISINONE
Dosage form CAPSULE
Route ORAL
Labeler Par Health USA, LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA211041
Pharmacologic classes 4-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]
Marketing start Oct 4, 2019
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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