NDC 65628-208 Firvanq

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

Product Information

NDC Product Code:
65628-208
Proprietary Name:
Firvanq
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]
Azurity Pharmaceuticals, Inc
Labeler Code:
65628
FDA Application Number: [6]
NDA208910
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
01-26-2018
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO ALMOST WHITE OR TAN TO BROWN)
WHITE (C48325)
Flavor(s):
GRAPE (C73391)

Product Packages

NDC Code 65628-208-10

Package Description: 1 KIT in 1 CARTON * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE

Product Details

What is NDC 65628-208?

The NDC code 65628-208 is assigned by the FDA to the product Firvanq which is a human prescription drug product labeled by Azurity Pharmaceuticals, Inc. The generic name of Firvanq is vancomycin hydrochloride. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 65628-208-10 1 kit in 1 carton * 15 g in 1 bottle * 289 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 Firvanq?

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.

Which are Firvanq UNII Codes?

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

Which are Firvanq 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 Firvanq?

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:

* Please review the disclaimer below.

Patient Education

Vancomycin


Vancomycin is used to treat colitis (inflammation of the intestine caused by certain bacteria) that may occur after antibiotic treatment. Vancomycin is in a class of medications called glycopeptide antibiotics. It works by killling bacteria in the intestines. Vancomycin will not kill bacteria or treat infections in any other part of the body when taken by mouth. Antibiotics such as vancomycin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
[Learn More]


Antibiotics


What are antibiotics?

Antibiotics are medicines that fight bacterial infections in people and animals. They work by killing the bacteria or by making it hard for the bacteria to grow and multiply.

Antibiotics can be taken in different ways:

  • Orally (by mouth). This could be pills, capsules, or liquids.
  • Topically. This might be a cream, spray, or ointment that you put on your skin. It could also be eye ointment, eye drops, or ear drops.
  • Through an injection or intravenously (IV). This is usually for more serious infections.

What do antibiotics treat?

Antibiotics only treat certain bacterial infections, such as strep throat, urinary tract infections, and E. coli.

You may not need to take antibiotics for some bacterial infections. For example, you might not need them for many sinus infections or some ear infections. Taking antibiotics when they're not needed won't help you, and they can have side effects. Your health care provider can decide the best treatment for you when you're sick. Don't ask your provider to prescribe an antibiotic for you.

Do antibiotics treat viral infections?

Antibiotics do not work on viral infections. For example, you shouldn't take antibiotics for:

What are the side effects of antibiotics?

The side effects of antibiotics range from minor to very severe. Some of the common side effects include:

More serious side effects can include:

Call your health care provider if you develop any side effects while taking your antibiotic.

Why is it important to take antibiotics only when they're needed?

You should only take antibiotics when they are needed because they can cause side effects and can contribute to antibiotic resistance. Antibiotic resistance happens when the bacteria change and become able to resist the effects of an antibiotic. This means that the bacteria continue to grow.

How do I use antibiotics correctly?

When you take antibiotics, it is important that you take them responsibly:

  • Always follow the directions carefully. Finish your medicine even if you feel better. If you stop taking them too soon, some bacteria may survive and re-infect you.
  • Don't save your antibiotics for later.
  • Don't share your antibiotic with others.
  • Don't take antibiotics prescribed for someone else. This may delay the best treatment for you, make you even sicker, or cause side effects.

Centers for Disease Control and Prevention


[Learn More]


* Please review the disclaimer below.

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".