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  5. NDC Package Code: 0641-6110-10 Sufentanil Citrate

NDC Package 0641-6110-10 Sufentanil Citrate

Injection Epidural; Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0641-6110-10
Package Description:
10 AMPULE in 1 CARTON / 1 mL in 1 AMPULE (0641-6110-01)
Product Code:
0641-6110
Proprietary Name:
Sufentanil Citrate
Non-Proprietary Name:
Sufentanil Citrate
Substance Name:
Sufentanil Citrate
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 bupivacaine, usually 12.5 mg per administration, during labor and vaginal delivery.SEE DOSAGE AND ADMINISTRATION SECTION FOR MORE COMPLETE INFORMATION ON THE USE OF SUFENTANIL.
11-Digit NDC Billing Format:
00641611010
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1809097 - SUFentanil 50 MCG in 1 ML Injection
  • RxCUI: 1809097 - 1 ML sufentanil 0.05 MG/ML Injection
  • RxCUI: 1809097 - sufentanil 50 MCG per 1 ML Injection
  • RxCUI: 1809102 - SUFentanil 100 MCG in 2 ML Injection
  • RxCUI: 1809102 - 2 ML sufentanil 0.05 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Epidural - Administration upon or over the dura mater.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • SUFENTANIL CITRATE .05 mg/mL
    • Pharmacologic Class(es):
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA074413
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-15-1995
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0641-6110-10?

    The NDC Packaged Code 0641-6110-10 is assigned to a package of 10 ampule in 1 carton / 1 ml in 1 ampule (0641-6110-01) of Sufentanil Citrate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is injection and is administered via epidural; intravenous form.

    Is NDC 0641-6110 included in the NDC Directory?

    Yes, Sufentanil Citrate with product code 0641-6110 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on December 15, 1995 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0641-6110-10?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0641-6110-10?

    The 11-digit format is 00641611010. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20641-6110-105-4-200641-6110-10