Ibuprofen Lysine Solution
NDC Package 66993-490-36

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

Package Information

Ibuprofen Lysine solution is ibuprofen Lysine is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. This formulation utilizes a solution delivery system. Marketed by Prasco Laboratories, this product is identified by NDC 66993-490 and is authorized under FDA application NDA021903.

Identification & Billing

NDC Package Code
66993-490-36
Package Description
3 VIAL in 1 CARTON / 2 mL in 1 VIAL
Product Code
66993-490
11-Digit Billing Format
66993049036
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ibuprofen Lysine
Non-Proprietary Name
Ibuprofen Lysine
Substance Name
Ibuprofen Lysine
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
IBUPROFEN LYSINE 10 mg/mL
Pharmacologic Class
Usage Information
Ibuprofen Lysine is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.

Regulatory & Marketing

Labeler Name
Prasco Laboratories
Product Type
Human Prescription Drug
FDA Application #
NDA021903
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
04-14-2016
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 66993-490-36 identifies a specific commercial package of 3 vial in 1 carton / 2 ml in 1 vial of Ibuprofen Lysine, a human prescription drug labeled by Prasco Laboratories. This solution is formulated for intravenous use and contains ibuprofen lysine 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 Prasco Laboratories on April 14, 2016. The current certification is valid through December 31, 2027.

How is this Prasco Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66993049036. 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:

10-Digit Format (5-3-2)
66993-490-36
11-Digit CMS (5-4-2)
66993-0490-36

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