Fentanyl Citrate Lozenge
NDC Package 0093-7868-65

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Fentanyl Citrate lozenges 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. This formulation utilizes a lozenge delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 0093-7868 and is authorized under FDA application NDA020747.

Identification & Billing

NDC Package Code
0093-7868-65
Package Description
30 BLISTER PACK in 1 CARTON / 1 LOZENGE in 1 BLISTER PACK (0093-7868-19)
Product Code
0093-7868
11-Digit Billing Format
00093786865
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fentanyl Citrate
Non-Proprietary Name
Fentanyl Citrate
Substance Name
Fentanyl Citrate
Dosage Form
Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
Administration Route
  • Oral - Administration to or by way of the mouth.
  • Transmucosal - Administration across the mucosa.
Active Ingredient(s)
FENTANYL CITRATE 800 ug/1
Pharmacologic Class
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).
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
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
12-08-2015
End Marketing Date
08-31-2026
Exclude Flag
N
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 0093-7868-65 identifies a specific commercial package of 30 blister pack in 1 carton / 1 lozenge in 1 blister pack (0093-7868-19) of Fentanyl Citrate, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. This lozenge is formulated for oral; transmucosal use and contains fentanyl citrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Teva Pharmaceuticals Usa, Inc. on December 08, 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 Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00093786865. 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 (4-4-2)
0093-7868-65
11-Digit CMS (5-4-2)
00093-7868-65

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