Javygtor Powder, For Solution
NDC 43598-162
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Javygtor (sapropterin dihydrochloride) is a ANDA-approved product labeled by Dr. Reddys Laboratories Inc. This medication is used along with diet changes for long-term treatment of a certain inherited disorder (phenylketonuria-PKU). It is supplied as a white powder, for solution for oral administration. This product entry covers the primary NDC 43598-162 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
43598-162
Proprietary Name:
Javygtor
Non-Proprietary Name: [1]
Sapropterin Dihydrochloride
Substance Name: [2]
Sapropterin Dihydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications
Dosage Form:
Powder, For Solution
- An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
43598
Product Label ID:
FDA Application Number: [6]
ANDA215798
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
11-16-2022
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325 - OFF WHITE TO PALE YELLOW)
Code Structure Chart
Product Details
What is NDC 43598-162?
The NDC code 43598-162 is assigned by the FDA to the product Javygtor. It is commonly known by its generic name, sapropterin dihydrochloride. This pharmaceutical product is labeled by Dr. Reddys Laboratories Inc and is currently categorized as listed product. The medication is a powder, for solution administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 43598-162-30. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
This medication is used along with diet changes for long-term treatment of a certain inherited disorder (phenylketonuria-PKU). It helps remove a certain chemical (phenylalanine) from the body. Too much phenylalanine in the body can cause brain damage.
What are Active Ingredients of this product?
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.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- SAPROPTERIN DIHYDROCHLORIDE (UNII: RG277LF5B3)
- SAPROPTERIN (UNII: EGX657432I) (Active Moiety)
Which are the Inactive Ingredients associated 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:
- ASCORBIC ACID (UNII: PQ6CK8PD0R)
- MANNITOL (UNII: 3OWL53L36A)
- SUCRALOSE (UNII: 96K6UQ3ZD4)
- POTASSIUM CITRATE (UNII: EE90ONI6FF)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 1653217 - sapropterin dihydrochloride 500 MG Powder for Oral Solution
- RxCUI: 2621237 - JAVYGTOR 500 MG Powder for Oral Solution
- RxCUI: 2621237 - sapropterin dihydrochloride 500 MG Powder for Oral Solution [Javygtor]
- RxCUI: 2621237 - Javygtor 500 MG Powder for Oral Solution
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
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Patient Education
Sapropterin
Sapropterin is used along with a restricted diet to control blood phenylalanine levels in adults and children 1 month of age and older who have phenylketonuria (PKU; an inborn condition in which phenylalanine may build up in the blood and causes decreased intelligence and a decreased ability to focus, remember, and organize information). Sapropterin will only work for some people who have PKU, and the only way to tell if sapropterin will help a particular patient is to give the medication for a period of time and see whether his or her phenylalanine level decreases. Sapropterin is in a class of medications called cofactors. It works by helping the body to break down phenylalanine so it will not build up in the blood.
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
