NDC 42457-420 Endari
Glutamine Powder, For Solution Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 42457 - Emmaus Medical, Inc.
- 42457-420 - Endari
Product Characteristics
Product Packages
NDC Code 42457-420-60
Package Description: 60 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET (42457-420-01)
Product Details
What is NDC 42457-420?
What are the uses for Endari?
What are Endari Active Ingredients?
- GLUTAMINE 5 g/1 - A non-essential amino acid present abundantly throughout the body and is involved in many metabolic processes. It is synthesized from GLUTAMIC ACID and AMMONIA. It is the principal carrier of NITROGEN in the body and is an important energy source for many cells.
Which are Endari UNII Codes?
The UNII codes for the active ingredients in this product are:
- GLUTAMINE (UNII: 0RH81L854J)
- GLUTAMINE (UNII: 0RH81L854J) (Active Moiety)
What is the NDC to RxNorm Crosswalk for Endari?
- RxCUI: 1869684 - glutamine 5 GM Powder for Oral Solution
- RxCUI: 1869684 - glutamine 5000 MG Powder for Oral Solution
- RxCUI: 1869684 - l-glutamine 5 GM Powder for Oral Solution
- RxCUI: 1928941 - Endari 5 GM Powder for Oral Solution
- RxCUI: 1928941 - glutamine 5000 MG Powder for Oral Solution [Endari]
Which are the Pharmacologic Classes for Endari?
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Patient Education
L-glutamine
L-glutamine is used to is used to reduce the frequency of painful episodes (crises) in adults and children 5 years of age and older with sickle cell anemia (an inherited blood disorder in which the red blood cells are abnormally shaped [shaped like a sickle] and cannot bring enough oxygen to all parts of the body). L-glutamine is in a class of medications called amino acids. It works by helping to prevent damage to red blood cells.
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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".