Fentanyl Citrate
NDC Package 55253-075-30

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 Cima Labs Inc., this product is identified by NDC 55253-075 and is authorized under FDA application NDA020747.

Identification & Billing

NDC Package Code
55253-075-30
Package Description
30 BLISTER PACK in 1 CARTON / 1 LOZENGE in 1 BLISTER PACK (55253-075-01)
Product Code
55253-075
11-Digit Billing Format
55253007530
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

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
Cima Labs Inc.
FDA Application #
NDA020747
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
01-20-1999
End Marketing Date
10-31-2016
Listing Expiration
10-31-2016
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 55253-075-30 identifies a specific commercial package of 30 blister pack in 1 carton / 1 lozenge in 1 blister pack (55253-075-01) of Fentanyl Citrate, labeled by Cima Labs Inc.. 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 Cima Labs Inc. on January 20, 1999. The current certification is valid through October 31, 2016.

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 Cima Labs Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55253007530. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
55253-075-30
11-Digit CMS (5-4-2)
55253-0075-30

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