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  4. NDC Product Code: 57885-0012 Vancomycin Hcl

NDC 57885-0012 Vancomycin Hcl

Powder - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 57885-0012?
  4. Vancomycin Hcl Uses
  5. Active Ingredients

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
57885-0012
Proprietary Name:
Vancomycin Hcl
Non-Proprietary Name: [1]
Vancomycin Hcl
Substance Name: [2]
Vancomycin Hydrochloride
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Labeler Name: [5]
Chongqing Daxin Pharmaceutical Co. Ltd.
Labeler Code:
57885
Marketing Category: [8]
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date: [9]
01-01-2020
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
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Product Details

What is NDC 57885-0012?

The NDC code 57885-0012 is assigned by the FDA to the UNFINISHED product Vancomycin Hcl which is a bulk ingredient product labeled by Chongqing Daxin Pharmaceutical Co. Ltd.. The generic name of Vancomycin Hcl is vancomycin hcl. The product's dosage form is powder. The product is distributed in a single package with assigned NDC code 57885-0012-2 10 kg in 1 bag . 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 Hcl?

Vancomycin is an antibiotic used to treat infections. This form of vancomycin is used to treat a certain intestinal condition (colitis) caused by bacteria. This condition causes diarrhea and stomach/abdominal discomfort or pain. When vancomycin is taken by mouth, it stays in the intestines to stop the growth of certain bacteria that cause these symptoms. This antibiotic treats only bacterial infection in the intestines. It will not work for bacterial infections in any other part of the body or for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

What are Vancomycin Hcl 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.
  • VANCOMYCIN HYDROCHLORIDE 1 kg/kg - Antibacterial obtained from Streptomyces orientalis. It is a glycopeptide related to RISTOCETIN that inhibits bacterial cell wall assembly and is toxic to kidneys and the inner ear.

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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.

[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.

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

[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".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.