Sufentanil Citrate Injection, Solution
NDC Package 0409-3382-49

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

Package Information

Sufentanil Citrate injection is indicated for intravenous administration in adults and pediatric patients:as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.Sufentanil Citrate Injection is indicated for epidural administration:as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery. This formulation utilizes a injection, solution delivery system. Marketed by Hospira, Inc., this product is identified by NDC 0409-3382 and is authorized under FDA application ANDA074534.

Identification & Billing

NDC Package Code
0409-3382-49
Package Description
10 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE
Product Code
0409-3382
11-Digit Billing Format
00409338249
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sufentanil Citrate
Non-Proprietary Name
Sufentanil Citrate
Substance Name
Sufentanil Citrate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Epidural - Administration upon or over the dura mater.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
SUFENTANIL CITRATE 50 ug/mL
Pharmacologic Class
Usage Information
Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients:as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.Sufentanil Citrate Injection is indicated for epidural administration:as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Hospira, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA074534
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-26-2005
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0409-3382). Click a package code to view its specific billing and regulatory data.

0409-3382-21
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3382-11)
0409-3382-50
10 VIAL, SINGLE-USE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-USE
0409-3382-51
10 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE

* 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 0409-3382-49 identifies a specific commercial package of 10 vial, single-use in 1 carton / 1 ml in 1 vial, single-use of Sufentanil Citrate, a human prescription drug labeled by Hospira, Inc.. This injection, solution is formulated for epidural; intravenous use and contains sufentanil 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 Hospira, Inc. on July 26, 2005. The current certification is valid through December 31, 2027.

How is this Hospira, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00409338249. 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)
0409-3382-49
11-Digit CMS (5-4-2)
00409-3382-49

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