Fentanyl Citrate
NDC Package 10019-033-72

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.

Fentanyl Citrate is a medication used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of opioid pain medication. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 10019-033 and is authorized under FDA application NDA019101.

Identification & Billing

NDC Package Code
10019-033-72
Package Description
10 AMPULE in 1 PACKAGE / 5 mL in 1 AMPULE (10019-033-39)
Product Code
10019-033
11-Digit Billing Format
10019003372
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Fentanyl Citrate
Dosage Form
-
Usage Information
This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of opioid pain medication. Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
FDA Application #
NDA019101
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-25-2010
End Marketing Date
05-31-2015
Listing Expiration
05-31-2015
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 10019-033-72 identifies a specific commercial package of 10 ampule in 1 package / 5 ml in 1 ampule (10019-033-39) of Fentanyl Citrate, labeled by Baxter Healthcare Corporation. 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 Baxter Healthcare Corporation on June 25, 2010. The current certification is valid through May 31, 2015.

What are the primary indications for this medication?

This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of opioid pain medication. Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10019003372. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
10019-033-72
11-Digit CMS (5-4-2)
10019-0033-72

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