Polocaine Injection, Solution
NDC Package 66312-441-16

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

Package Information

Polocaine (mepivacaine hydrochloride) injection is mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients. This formulation utilizes a injection, solution delivery system. Marketed by Dentsply Pharmaceutical, this product is identified by NDC 66312-441 and is authorized under FDA application ANDA088387.

Identification & Billing

NDC Package Code
66312-441-16
Package Description
50 CARTRIDGE in 1 CARTON / 1.7 mL in 1 CARTRIDGE
Product Code
66312-441
11-Digit Billing Format
66312044116
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Polocaine
Non-Proprietary Name
Mepivacaine Hydrochloride
Substance Name
Mepivacaine 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)
MEPIVACAINE HYDROCHLORIDE 30 mg/mL
Pharmacologic Class
Usage Information
Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.

Regulatory & Marketing

Labeler Name
Dentsply Pharmaceutical
Product Type
Human Prescription Drug
FDA Application #
ANDA088387
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-10-1984
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 66312-441-16 identifies a specific commercial package of 50 cartridge in 1 carton / 1.7 ml in 1 cartridge of Polocaine, a human prescription drug labeled by Dentsply Pharmaceutical. This injection, solution is formulated for submucosal use and contains mepivacaine 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 Dentsply Pharmaceutical on October 10, 1984. The current certification is valid through December 31, 2026.

How is this Dentsply Pharmaceutical product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66312044116. 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)
66312-441-16
11-Digit CMS (5-4-2)
66312-0441-16

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