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  5. NDC Package Code: 43598-548-21 Propofol Injectable Emulsion

NDC Package 43598-548-21 Propofol Injectable Emulsion

Injection, Emulsion Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
43598-548-21
Package Description:
20 VIAL in 1 CARTON / 50 mL in 1 VIAL (43598-548-50)
Product Code:
43598-548
Proprietary Name:
Propofol Injectable Emulsion
Non-Proprietary Name:
Propofol Injectable Emulsion
Substance Name:
Propofol
Usage Information:
Propofol injectable emulsion, USP is an IV general anesthetic and sedation drug that  can be used as described in the table below.. Table 3. Indications for Propofol Injectable Emulsion, USP IndicationApproved Patient PopulationInitiation and maintenance of MonitoredAdults onlyAnesthesia Care (MAC) sedationCombined sedation and regional anesthesia Adults only (see PRECAUTIONS)Induction of General Anesthesia Maintenance of General AnesthesiaPatients greater than or equal to 3 years of age Patients greater than or equal to 2 months of ageIntensive Care Unit (ICU) sedation of intubated, mechanically ventilated patientsAdults onlySafety, effectiveness and dosing guidelines for propofol injectable emulsion, USP have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see PRECAUTIONS, Pediatric Use). Propofol injectable emulsion, USP is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations.In the Intensive Care Unit (ICU), propofol injectable emulsion, USP can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.Propofol injectable emulsion, USP is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established (see PRECAUTIONS, Pediatric Use). Propofol injectable emulsion, USP is not recommended for obstetrics, including Cesarean section deliveries. Propofol injectable emulsion, USP crosses the placenta, and as with other general anesthetic agents, the administration of propofol injectable emulsion, USP may be associated with neonatal depression (see PRECAUTIONS).Propofol injectable emulsion, USP is not recommended for use in nursing mothers because propofol has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol, USP are not known (see PRECAUTIONS).
11-Digit NDC Billing Format:
43598054821
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1808217 - propofol 1000 MG in 100 ML Injection
  • RxCUI: 1808217 - 100 ML propofol 10 MG/ML Injection
  • RxCUI: 1808217 - propofol 1000 MG per 100 ML Injection
  • RxCUI: 1808222 - propofol 500 MG in 50 ML Injection
  • RxCUI: 1808222 - 50 ML propofol 10 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dr. Reddy's Laboratories, Inc.
    Dosage Form:
    Injection, Emulsion - An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • PROPOFOL 10 mg/mL
    • Pharmacologic Class(es):
  • General Anesthesia - [PE] (Physiologic Effect)
  • General Anesthetic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA205067
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-15-2018
    Listing Expiration Date:
    12-31-2024
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 43598-548-21 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    43598054821J2704Inj, propofol, 10 mg10 MG5020501000

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43598-548-21?

    The NDC Packaged Code 43598-548-21 is assigned to a package of 20 vial in 1 carton / 50 ml in 1 vial (43598-548-50) of Propofol Injectable Emulsion, a human prescription drug labeled by Dr. Reddy's Laboratories, Inc.. The product's dosage form is injection, emulsion and is administered via intravenous form.

    Is NDC 43598-548 included in the NDC Directory?

    Yes, Propofol Injectable Emulsion with product code 43598-548 is active and included in the NDC Directory. The product was first marketed by Dr. Reddy's Laboratories, Inc. on November 15, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 43598-548-21?

    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 43598-548-21?

    The 11-digit format is 43598054821. 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 5-3-2 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
    5-3-243598-548-215-4-243598-0548-21