NDC Package 83634-603-50 Propofol

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

Package Information
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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:

83634-603-50

Package Description:

20 VIAL in 1 CARTON / 50 mL in 1 VIAL (83634-603-42)

Product Code:

83634-603

Proprietary Name:

Propofol

Non-Proprietary Name:

Propofol

Substance Name:

Propofol

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)].

11-Digit NDC Billing Format:

83634060350

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:

Avenacy 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):

Sample Package:

FDA Application Number:

ANDA206408

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

01-15-2025

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

83634 - Avenacy Inc.
- 83634-603 - Propofol
  - 83634-603-50 - 20 VIAL in 1 CARTON / 50 mL in 1 VIAL (83634-603-42)

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
83634-603-20	20 VIAL in 1 CARTON / 20 mL in 1 VIAL (83634-603-41)
83634-603-51	10 VIAL in 1 CARTON / 100 mL in 1 VIAL (83634-603-43)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 83634-603-50?

The NDC Packaged Code 83634-603-50 is assigned to a package of 20 vial in 1 carton / 50 ml in 1 vial (83634-603-42) of Propofol, a human prescription drug labeled by Avenacy Inc.. The product's dosage form is injection, emulsion and is administered via intravenous form.

Is NDC 83634-603 included in the NDC Directory?

Yes, Propofol with product code 83634-603 is active and included in the NDC Directory. The product was first marketed by Avenacy Inc. on January 15, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 83634-603-50?

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 83634-603-50?

The 11-digit format is 83634060350. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	83634-603-50	5-4-2	83634-0603-50

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