1. Home
  2. Labeler Index
  3. Galentic Pharma (india) Priva Te Ltd.
  4. NDC Product Code: 50382-002 Saline Enema

NDC 50382-002 Saline Enema

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 50382-002?
  4. Saline Enema Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
50382-002
Proprietary Name:
Saline Enema
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Galentic Pharma (india) Priva Te Ltd.
Labeler Code:
50382
Product Label ID:
619f934e-ac71-4447-a17b-1a30d1073b36
Start Marketing Date: [9]
08-01-2013
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Code Structure Chart

Product Details

What is NDC 50382-002?

The NDC code 50382-002 is assigned by the FDA to the product Saline Enema which is product labeled by Galentic Pharma (india) Priva Te Ltd.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 50382-002-01 118 ml 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 Saline Enema?

Do not use more unless directed by a doctorSee WarningsAdults and children 12 years and older - 1 bottleChildren 2 to under 12 years - 1/2 bottleChildren under 2 years - Do not use. Consult a physician.

Which are Saline Enema UNII Codes?

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

Which are Saline Enema 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:

What is the NDC to RxNorm Crosswalk for Saline Enema?

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: 283100 - sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML Enema
  • RxCUI: 283100 - sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema
  • RxCUI: 283100 - sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema
  • RxCUI: 283100 - sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema

* 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.

[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".