Tigecycline
NDC 63323-960
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Tigecycline is a NDA-approved product labeled by Fresenius Kabi Usa, Llc. Tigecycline is used to treat certain serious bacterial infections when other antibiotics may not work. It is supplied as a product. This product entry covers the primary NDC 63323-960 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
63323-960
Proprietary Name:
Tigecycline
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
63323
Product Label ID:
FDA Application Number: [6]
NDA205645
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
12-01-2016
End Marketing Date: [10]
01-17-2025
Listing Expiration Date: [11]
01-17-2025
Exclude Flag: [12]
D
Code Structure Chart
Product Details
What is NDC 63323-960?
The NDC code 63323-960 is assigned by the FDA to the product Tigecycline. This pharmaceutical product is labeled by Fresenius Kabi Usa, Llc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 63323-960-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Tigecycline is used to treat certain serious bacterial infections when other antibiotics may not work. It is related to a class of drugs known as tetracycline antibiotics. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work 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 the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- TIGECYCLINE (UNII: 70JE2N95KR)
- TIGECYCLINE (UNII: 70JE2N95KR) (Active Moiety)
Which are the Inactive Ingredients associated 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:
- ARGININE (UNII: 94ZLA3W45F)
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Patient Education
Tigecycline Injection
Tigecycline injection used to treat certain serious infections including community acquired pneumonia (a lung infection that developed in a person who was not in the hospital), skin infections, and infections of the abdomen (area between the chest and the waist). Tigecycline injection should not be used to treat pneumonia that developed in people who are on ventilators or who were in a hospital or foot infections in people who have diabetes. Tigecycline injection is in a class of medications called tetracycline antibiotics. It works by killing bacteria that cause infection. Antibiotics such as tigecycline injection will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
