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  4. NDC Product Code: 52536-104 Vancomycin Hydrochloride For Oral Solution

NDC 52536-104 Vancomycin Hydrochloride For Oral Solution

Vancomycin Hydrochloride Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 52536-104?
  5. Vancomycin Hydrochloride For Oral Solution Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
52536-104
Proprietary Name:
Vancomycin Hydrochloride For Oral Solution
Non-Proprietary Name: [1]
Vancomycin Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Wilshire Pharmaceuticals, Inc.
Labeler Code:
52536
Product Label ID:
4c3d2e99-5351-4442-916a-d2001b0a5f5a
FDA Application Number: [6]
NDA208910
Marketing Category: [8]
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date: [9]
03-31-2023
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Flavor(s):
GRAPE (C73391)

Code Structure Chart

Product Details

What is NDC 52536-104?

The NDC code 52536-104 is assigned by the FDA to the product Vancomycin Hydrochloride For Oral Solution which is a human prescription drug product labeled by Wilshire Pharmaceuticals, Inc.. The generic name of Vancomycin Hydrochloride For Oral Solution is vancomycin hydrochloride. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 52536-104-05 1 kit in 1 carton * 3.75 g in 1 bottle (52536-094-05) * 147 ml in 1 bottle (52536-084-05). 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 Vancomycin Hydrochloride For Oral Solution?

Vancomycin hydrochloride is indicated for the treatment of Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age.Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age.Important Limitations of Use•Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.•Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.To reduce the development of drug‑resistant bacteria and maintain the effectiveness of vancomycin hydrochloride and other antibacterial drugs, vancomycin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Which are Vancomycin Hydrochloride For Oral Solution UNII Codes?

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

Which are Vancomycin Hydrochloride For Oral Solution 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 Vancomycin Hydrochloride 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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Product Footnotes

[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.

[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.

[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".