Na
NDC Package 83090-005-10

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.

Na is lidocaine Hydrochloride Injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Marketed by Sintetica Us Llc, this product is identified by NDC 83090-005 and is authorized under FDA application ANDA214267.

Identification & Billing

NDC Package Code
83090-005-10
Package Description
10 AMPULE in 1 CARTON / 5 mL in 1 AMPULE (83090-005-01)
Product Code
83090-005
11-Digit Billing Format
83090000510
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Na
Dosage Form
-
Usage Information
Lidocaine Hydrochloride Injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.

Regulatory & Marketing

Labeler Name
Sintetica Us Llc
FDA Application #
ANDA214267
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-15-2022
Listing Expiration
12-31-2025
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.

* 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 83090-005-10 identifies a specific commercial package of 10 ampule in 1 carton / 5 ml in 1 ampule (83090-005-01) of Na, labeled by Sintetica Us Llc. 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 Sintetica Us Llc on November 15, 2022. The current certification is valid through December 31, 2025.

How is this Sintetica Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83090000510. 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)
83090-005-10
11-Digit CMS (5-4-2)
83090-0005-10

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