Vivacaine Injection, Solution
NDC Package 0362-9011-10

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

Package Information

Vivacaine (bupivacaine hydrochloride and epinephrine bitartrate) injection is vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) is indicated for the production of local anesthesia for dental procedures by infiltration injection or nerve block in adults.Vivacaine® is not recommended for children. This formulation utilizes a injection, solution delivery system. Marketed by Septodont, Inc., this product is identified by NDC 0362-9011 and is authorized under FDA application ANDA077250.

Identification & Billing

NDC Package Code
0362-9011-10
Package Description
10 CARTRIDGE in 1 CARTON / 1.8 mL in 1 CARTRIDGE
Product Code
0362-9011
11-Digit Billing Format
00362901110
RxNorm Crosswalk
  • RxCUI: 1012461 - Vivacaine 5 % / EPINEPHrine 1:200,000 in 1.8 ML Dental Cartridge
  • RxCUI: 1012461 - 1.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Cartridge [Vivacaine]
  • RxCUI: 1012461 - Vivacaine (bupivacaine HCl 5 % / epinephrine (as epinephrine bitartrate) 1:200,000) in 1.8 mL Cartridge
  • RxCUI: 1670365 - BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 1.8 ML Dental Cartridge
  • RxCUI: 1670365 - 1.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Cartridge

Clinical Specifications

Proprietary Name
Vivacaine
Non-Proprietary Name
Bupivacaine Hydrochloride And Epinephrine Bitartrate
Substance Name
Bupivacaine Hydrochloride Anhydrous; Epinephrine Bitartrate
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
Vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) is indicated for the production of local anesthesia for dental procedures by infiltration injection or nerve block in adults.Vivacaine® is not recommended for children.

Regulatory & Marketing

Labeler Name
Septodont, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA077250
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2013
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0362-9011). Click a package code to view its specific billing and regulatory data.

0362-9011-50
50 CARTRIDGE in 1 CARTON / 1.8 mL in 1 CARTRIDGE

* 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 0362-9011-10 identifies a specific commercial package of 10 cartridge in 1 carton / 1.8 ml in 1 cartridge of Vivacaine, a human prescription drug labeled by Septodont, Inc.. This injection, solution is formulated for submucosal use and contains bupivacaine hydrochloride anhydrous; epinephrine bitartrate 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 June 01, 2013. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00362901110. 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)
0362-9011-10
11-Digit CMS (5-4-2)
00362-9011-10

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