Diprivan
NDC Package 52584-269-50

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Diprivan is injectable Emulsion is an IV sedative-hypnotic agent that can be used as described in the table below.  Table 3. Marketed by General Injectables & Vaccines, Inc, this product is identified by NDC 52584-269 and is authorized under FDA application NDA019627.

Identification & Billing

NDC Package Code
52584-269-50
Package Description
1 VIAL in 1 BAG / 50 mL in 1 VIAL
Product Code
52584-269
11-Digit Billing Format
52584026950
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diprivan
Dosage Form
-
Usage Information
DIPRIVAN Injectable Emulsion is an IV sedative-hypnotic agent that can be used as described in the table below.  Table 3.  Indications for DIPRIVAN Injectable EmulsionIndicationApproved  Patient PopulationInitiation and maintenance of Monitored Anesthesia Care (MAC) sedationAdults onlyCombined sedation and reginoal anesthesiaAdults only (see PRECAUTIONS)Induction of General AnesthesiaPatients more than or equal to 3 years of ageMaintenance of General AnesthesiaPatients more than or equal to 2 years of ageIntensive Care Unit (ICU) sedation of intubated, mechanically ventilated patientsAdults onlySafety, effectiveness and dosing guidelines for DIPRIVAN 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). DIPRIVAN 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), DIPRIVAN 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. DIPRIVAN 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). DIPRIVAN Injectable Emulsion is not recommended for obstetrics, including Cesarean section deliveries.  DIPRIVAN Injectable Emulsion crosses the placenta, and as with other general anesthetic agents, the administration of DIPRIVAN Injectable Emulsion may be associated with neonatal depression (see PRECAUTIONS). DIPRIVAN Injectable Emulsion is not recommended for use in nursing mothers because DIPRIVAN Injectable Emulsion 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
General Injectables & Vaccines, Inc
FDA Application #
NDA019627
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-01-2010
Listing Expiration
12-31-2018
Exclude Flag
I
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52584-269-50 identifies a specific commercial package of 1 vial in 1 bag / 50 ml in 1 vial of Diprivan, labeled by General Injectables & Vaccines, Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by General Injectables & Vaccines, Inc on March 01, 2010. The current certification is valid through December 31, 2018.

How is this General Injectables & Vaccines, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52584026950. 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)
52584-269-50
11-Digit CMS (5-4-2)
52584-0269-50

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