Tigecycline
NDC Package 63323-960-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Tigecycline is used to treat certain serious bacterial infections when other antibiotics may not work. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-960 and is authorized under FDA application NDA205645.

Identification & Billing

NDC Package Code
63323-960-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (63323-960-01)
Product Code
63323-960
11-Digit Billing Format
63323096010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Tigecycline
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
FDA Application #
NDA205645
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-01-2016
End Marketing Date
01-17-2025
Listing Expiration
01-17-2025
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63323-960-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (63323-960-01) of Tigecycline, labeled by Fresenius Kabi Usa, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Fresenius Kabi Usa, Llc on December 01, 2016. The current certification is valid through January 17, 2025.

What are the primary indications for this medication?

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.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323096010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
63323-960-10
11-Digit CMS (5-4-2)
63323-0960-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.