Flavalta Injection, Solution
NDC Package 0362-1200-50

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

Package Information

Flavalta (lidocaine hydrochloride and epinephrine) injection is fLAVALTA solution is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques [see Dosage and Administration (2.2)]. This formulation utilizes a injection, solution delivery system. Marketed by Septodont, Inc., this product is identified by NDC 0362-1200 and is authorized under FDA application NDA216564.

Identification & Billing

NDC Package Code
0362-1200-50
Package Description
50 CARTRIDGE in 1 CARTON / 1.7 mL in 1 CARTRIDGE
Product Code
0362-1200
11-Digit Billing Format
00362120050
RxNorm Crosswalk
  • RxCUI: 1293648 - lidocaine HCl 2 % / EPINEPHrine 1:100,000 in 1.7 mL Dental Cartridge
  • RxCUI: 1293648 - 1.7 ML epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Cartridge
  • RxCUI: 1293648 - lidocaine HCl 2 % / epinephrine 1:100,000 1.7 ML Dental Cartridge
  • RxCUI: 1293648 - lidocaine HCl 2 % with epinephrine 1:100,000 1.7 ML Dental Cartridge
  • RxCUI: 2739501 - Flavalta 2 % / 1:100,000 1.7 ML Dental Cartridge

Clinical Specifications

Proprietary Name
Flavalta
Non-Proprietary Name
Lidocaine Hydrochloride And Epinephrine
Substance Name
Epinephrine Bitartrate; Lidocaine Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Submucosal - Administration beneath the mucous membrane.
Active Ingredient(s)
Pharmacologic Class
Usage Information
FLAVALTA solution is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques [see Dosage and Administration (2.2)].

Regulatory & Marketing

Labeler Name
Septodont, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA216564
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-19-2026
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 0362-1200-50 identifies a specific commercial package of 50 cartridge in 1 carton / 1.7 ml in 1 cartridge of Flavalta, a human prescription drug labeled by Septodont, Inc.. This injection, solution is formulated for submucosal use and contains epinephrine bitartrate; lidocaine hydrochloride 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 Septodont, Inc. on March 19, 2026. The current certification is valid through December 31, 2027.

How is this Septodont, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00362120050. 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 (4-4-2)
0362-1200-50
11-Digit CMS (5-4-2)
00362-1200-50

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