Fentanyl Citrate Injection
NDC Package 0641-6249-10

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

Package Information

Fentanyl Citrate injection 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 injection delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0641-6249 and is authorized under FDA application NDA019101.

Identification & Billing

NDC Package Code
0641-6249-10
Package Description
10 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS (0641-6249-01)
Product Code
0641-6249
11-Digit Billing Format
00641624910
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fentanyl Citrate
Non-Proprietary Name
Fentanyl Citrate
Substance Name
Fentanyl Citrate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
FENTANYL CITRATE 50 ug/mL
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
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA019101
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-01-2023
Listing Expiration
12-31-2027
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 0641-6249-10 identifies a specific commercial package of 10 syringe, glass in 1 carton / .5 ml in 1 syringe, glass (0641-6249-01) of Fentanyl Citrate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This injection is formulated for intramuscular; intravenous 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 Hikma Pharmaceuticals Usa Inc. on February 01, 2023. The current certification is valid through December 31, 2027.

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 Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00641624910. 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 (4-4-2)
0641-6249-10
11-Digit CMS (5-4-2)
00641-6249-10

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