Na
NDC Package 68055-649-10

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 is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Marketed by Sintetica Sa, this product is identified by NDC 68055-649 and is authorized under FDA application ANDA214269.

Identification & Billing

NDC Package Code
68055-649-10
Package Description
10 AMPULE in 1 CARTON / 5 mL in 1 AMPULE (68055-649-01)
Product Code
68055-649
11-Digit Billing Format
68055064910
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Na
Dosage Form
-
Usage Information
Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Regulatory & Marketing

Labeler Name
Sintetica Sa
FDA Application #
ANDA214269
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-05-2022
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 68055-649-10 identifies a specific commercial package of 10 ampule in 1 carton / 5 ml in 1 ampule (68055-649-01) of Na, labeled by Sintetica Sa. 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 Sa on May 05, 2022. The current certification is valid through December 31, 2025.

How is this Sintetica Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68055064910. 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)
68055-649-10
11-Digit CMS (5-4-2)
68055-0649-10

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