Propofol Injection, Emulsion
NDC Package 36000-058-10

11-digit billing NDC: 36000005810
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Propofol injection is propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for:•Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age•Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age•Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients•Sedation for Adult Patients in Combination with Regional Anesthesia•Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients Limitations of UsePropofol injectable emulsion 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 [see Pediatric Use (8.4)].Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use (8.4)].Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4)]. This formulation utilizes a injection, emulsion delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 36000-058 and is authorized under FDA application ANDA203421.

Identification & Billing

NDC Package Code
36000-058-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE (36000-058-01)
Product Code
36000-058
11-Digit Billing Format
36000005810

Clinical Specifications

Proprietary Name
Propofol
Non-Proprietary Name
Propofol
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 is an intravenous general anesthetic and sedation drug indicated for:•Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age•Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age•Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients•Sedation for Adult Patients in Combination with Regional Anesthesia•Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients Limitations of UsePropofol injectable emulsion 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 [see Pediatric Use (8.4)].Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use (8.4)].Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4)].

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA203421
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-03-2026
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 36000-058-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose (36000-058-01) of Propofol, a human prescription drug labeled by Baxter Healthcare Corporation. 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 Baxter Healthcare Corporation on November 03, 2026. The current certification is valid through December 31, 2027.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36000005810. 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)
36000-058-10
11-Digit CMS (5-4-2)
36000-0058-10

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