Propofol Injection, Emulsion
NDC Package 0069-0248-01

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

Propofol injection is propofol Injectable Emulsion is an intravenous general anesthetic and sedation drug that can be used as described in the table below.Table 3 Indications for Propofol Injectable EmulsionIndicationApproved Patient PopulationInitiation and maintenance of Monitored Anesthesia Care (MAC) sedationAdults onlyCombined sedation and regional anesthesiaAdults only (see PRECAUTIONS)Induction of General AnesthesiaPatients ≥ 3 years of ageMaintenance of General AnesthesiaPatients ≥ 2 months of ageIntensive Care Unit (ICU) sedation of intubated, mechanically ventilated patientsAdults onlySafety, 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 PRECAUTIONS, Pediatric Use).Propofol 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.In the Intensive Care Unit (ICU), Propofol Injectable Emulsion 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 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 is not recommended for obstetrics, including Cesarean section deliveries. This formulation utilizes a injection, emulsion delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0069-0248 and is authorized under FDA application ANDA205576.

Identification & Billing

NDC Package Code
0069-0248-01
Package Description
1 VIAL in 1 CARTON / 100 mL in 1 VIAL
Product Code
0069-0248
11-Digit Billing Format
00069024801
RxNorm Crosswalk

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 that can be used as described in the table below.Table 3 Indications for Propofol Injectable EmulsionIndicationApproved Patient PopulationInitiation and maintenance of Monitored Anesthesia Care (MAC) sedationAdults onlyCombined sedation and regional anesthesiaAdults only (see PRECAUTIONS)Induction of General AnesthesiaPatients ≥ 3 years of ageMaintenance of General AnesthesiaPatients ≥ 2 months of ageIntensive Care Unit (ICU) sedation of intubated, mechanically ventilated patientsAdults onlySafety, 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 PRECAUTIONS, Pediatric Use).Propofol 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.In the Intensive Care Unit (ICU), Propofol Injectable Emulsion 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 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 is not recommended for obstetrics, including Cesarean section deliveries. Propofol Injectable Emulsion crosses the placenta, and as with other general anesthetic agents, the administration of Propofol Injectable Emulsion may be associated with neonatal depression (see PRECAUTIONS).Propofol Injectable Emulsion 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 are not known (see PRECAUTIONS).

Regulatory & Marketing

Labeler Name
Pfizer Laboratories Div Pfizer Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA205576
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-05-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0069-0248). Click a package code to view its specific billing and regulatory data.

0069-0248-10
10 VIAL in 1 CARTON / 100 mL in 1 VIAL

* 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 0069-0248-01 identifies a specific commercial package of 1 vial in 1 carton / 100 ml in 1 vial of Propofol, a human prescription drug labeled by Pfizer Laboratories Div Pfizer 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 Pfizer Laboratories Div Pfizer Inc on October 05, 2020. The current certification is valid through December 31, 2026.

How is this Pfizer Laboratories Div Pfizer Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00069024801. 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)
0069-0248-01
11-Digit CMS (5-4-2)
00069-0248-01

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