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  4. NDC Product Code: 43598-749 Sapropterin Dihydrochloride

NDC 43598-749 Sapropterin Dihydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 43598-749?
  5. Sapropterin Dihydrochloride Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 43598-749 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
43598-749
Proprietary Name:
Sapropterin Dihydrochloride
Product Type: [3]
Labeler Name: [5]
Dr. Reddys Laboratories Inc.
Labeler Code:
43598
Product Label ID:
83bf50fd-f70c-037a-5c8f-b32f69208d20
FDA Application Number: [6]
NDA022181
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
10-01-2020
End Marketing Date: [10]
10-31-2023
Listing Expiration Date: [11]
10-31-2023
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - OFF-WHITE TO LIGHT YELLOW)
Shape:
ROUND (C48348)
Size(s):
10 MM
Imprint(s):
177
Score:
1

Code Structure Chart

Product Details

What is NDC 43598-749?

The NDC code 43598-749 is assigned by the FDA to the product Sapropterin Dihydrochloride which is product labeled by Dr. Reddys Laboratories Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 43598-749-04 1 bottle in 1 carton / 120 tablet in 1 bottle, 43598-749-13 8000 bottle in 1 case / 120 tablet in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Sapropterin Dihydrochloride?

Sapropterin dihydrochloride tablets are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride is to be used in conjunction with a Phe-restricted diet.

What are Sapropterin Dihydrochloride Active Ingredients?

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 Sapropterin Dihydrochloride UNII Codes?

The UNII codes for the active ingredients in this product are:

* Please review the disclaimer below.

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 disclaimer below.

Product Footnotes

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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, 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".