Diprivan Injection, Emulsion
NDC Package 63323-269-77
Package Information
Diprivan (propofol) injection is dIPRIVAN 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 PatientsLimitations of UseDIPRIVAN 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 DIPRIVAN have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use (8.4)].DIPRIVAN 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 Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-269 and is authorized under FDA application NDA019627.
Identification & Billing
- 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: 1808219 - DIPRIVAN 1000 MG in 100 ML Injection
- RxCUI: 1808219 - 100 ML propofol 10 MG/ML Injection [Diprivan]
Clinical Specifications
- Intravenous - Administration within or into a vein or veins.
- Intravenous - Administration within or into a vein or veins.
- Intravenous - Administration within or into a vein or veins.
- Intravenous - Administration within or into a vein or veins.
- General Anesthesia - [PE] (Physiologic Effect)
- General Anesthetic - [EPC] (Established Pharmacologic Class)
- General Anesthesia - [PE] (Physiologic Effect)
- General Anesthetic - [EPC] (Established Pharmacologic Class)
- General Anesthesia - [PE] (Physiologic Effect)
- General Anesthetic - [EPC] (Established Pharmacologic Class)
- General Anesthesia - [PE] (Physiologic Effect)
- General Anesthetic - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 63323 - Fresenius Kabi Usa, Llc
- 63323-269 - Diprivan
- 63323-269-77 - 20 VIAL in 1 BOX / 50 mL in 1 VIAL (63323-269-75)
- 63323-269 - Diprivan
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 (63323-269). Click a package code to view its specific billing and regulatory data.
* 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 63323-269-77 identifies a specific commercial package of 20 vial in 1 box / 50 ml in 1 vial (63323-269-75) of Diprivan, a human prescription drug labeled by Fresenius Kabi Usa, Llc. 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 Fresenius Kabi Usa, Llc on November 17, 2009. The current certification is valid through December 31, 2026.
How is this Fresenius Kabi Usa, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323026977. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
