Propofol Injectable Emulsion Injection, Emulsion
NDC Package 43598-548-21

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

Package Information

Propofol Injectable Emulsion injection is propofol injectable emulsion, USP is an IV general anesthetic and sedation drug that  can be used as described in the table below.. Table 3. This formulation utilizes a injection, emulsion delivery system. Marketed by Dr. Reddy's Laboratories, Inc., this product is identified by NDC 43598-548 and is authorized under FDA application ANDA205067.

Identification & Billing

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
11-Digit Billing Format
43598054821
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Propofol Injectable Emulsion
Non-Proprietary Name
Propofol Injectable Emulsion
Substance Name
Propofol
Dosage Form
Injection, Emulsion - An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
PROPOFOL 10 mg/mL
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205067
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-15-2018
Listing Expiration
12-31-2026
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J2704
Source: PDAC
INJECTION, PROPOFOL, 10 MG
HCPCS Dosage 10 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 43598-548-21 identifies a specific commercial 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.. This injection, emulsion is formulated for intravenous use and contains propofol 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 Dr. Reddy's Laboratories, Inc. on November 15, 2018. The current certification is valid through December 31, 2026.

How is this Dr. Reddy's Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598054821. 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 (5-3-2)
43598-548-21
11-Digit CMS (5-4-2)
43598-0548-21

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