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  4. NDC Product Code: 55792-002 Betaine Anhydrous For Oral Solution

NDC 55792-002 Betaine Anhydrous For Oral Solution

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 55792-002?
  5. Betaine Anhydrous For Oral Solution Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
55792-002
Proprietary Name:
Betaine Anhydrous For Oral Solution
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Lukare Medical, Llc
Labeler Code:
55792
Product Label ID:
ef44452a-5707-0d39-cbba-2fa285fb994c
Start Marketing Date: [9]
02-11-2022
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)

Product Packages

NDC Code 55792-002-01

Package Description: 180 g in 1 BOTTLE

Product Details

What is NDC 55792-002?

The NDC code 55792-002 is assigned by the FDA to the product Betaine Anhydrous For Oral Solution which is product labeled by Lukare Medical, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 55792-002-01 180 g 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 Betaine Anhydrous For Oral Solution?

Betaine Anhydrous for Oral Solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Included within the category of homocystinuria are: •Cystathionine beta-synthase (CBS) deficiency•5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency•Cobalamin cofactor metabolism (cbl) defect

Which are Betaine Anhydrous For Oral Solution UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Betaine Anhydrous For Oral Solution?

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:

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Patient Education

Betaine


Betaine is used to treat homocystinuria (an inherited condition in which the body cannot break down a certain protein, causing build-up of homocysteine in the blood). Increased amounts of homocysteine in the body can cause symptoms such as extreme tiredness, seizures, dislocation of the lens of the eye, abnormal bone structure, osteoporosis (weak bones), blood clots, or decreased weight or rate of weight gain and slowed development in children. Betaine is in a class of medications called nutrients. It works by decreasing the amount of homocysteine in the blood.
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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".