NDC 65597-407 Turalio
Pexidartinib Hydrochloride Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
BLUE (C48333 - POWDER BLUE OPAQUE CAP)
Code Structure Chart
Product Details
What is NDC 65597-407?
What are the uses for Turalio?
What are Turalio Active Ingredients?
Which are Turalio UNII Codes?
The UNII codes for the active ingredients in this product are:
- PEXIDARTINIB HYDROCHLORIDE (UNII: YS6WAI3XN7)
- PEXIDARTINIB (UNII: 6783M2LV5X) (Active Moiety)
Which are Turalio Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- POLOXAMER 407 (UNII: TUF2IVW3M2)
- MANNITOL (UNII: 3OWL53L36A)
- CROSPOVIDONE (UNII: 2S7830E561)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
What is the NDC to RxNorm Crosswalk for Turalio?
- RxCUI: 2626397 - pexidartinib 125 MG Oral Capsule
- RxCUI: 2626399 - Turalio 125 MG Oral Capsule
- RxCUI: 2626399 - pexidartinib 125 MG Oral Capsule [Turalio]
Which are the Pharmacologic Classes for Turalio?
- Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors - [MoA] (Mechanism of Action)
- Cytochrome P450 2B6 Inhibitors - [MoA] (Mechanism of Action)
- Cytochrome P450 3A Inducers - [MoA] (Mechanism of Action)
- Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
- Kinase Inhibitors - [MoA] (Mechanism of Action)
- Tyrosine Kinase Inhibitors - [MoA] (Mechanism of Action)
- UGT1A1 Inhibitors - [MoA] (Mechanism of Action)
* Please review the disclaimer below.
Patient Education
Pexidartinib
Pexidartinib is used to treat tenosynovial giant cell tumors (TGCT; tumors in or around a joint that can cause pain, swelling, and reduce movement) in adults that cannot be treated by surgery. Pexidartinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that may help the tumor to shrink.
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".