Anestacon
NDC Package 50383-772-15

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.

Anestacon is lidocaine hydrochloride jelly USP, 2% (Anestacon®) is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal). Marketed by Hi-tech Pharmacal Co., Inc., this product is identified by NDC 50383-772 and is authorized under FDA application ANDA080429.

Identification & Billing

NDC Package Code
50383-772-15
Package Description
1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE
Product Code
50383-772
11-Digit Billing Format
50383077215
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Anestacon
Dosage Form
-
Usage Information
Lidocaine hydrochloride jelly USP, 2% (Anestacon®) is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).

Regulatory & Marketing

Labeler Name
Hi-tech Pharmacal Co., Inc.
FDA Application #
ANDA080429
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-05-2001
Listing Expiration
12-31-2017
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 50383-772-15 identifies a specific commercial package of 1 bottle in 1 carton / 15 ml in 1 bottle of Anestacon, labeled by Hi-tech Pharmacal Co., Inc.. 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 Hi-tech Pharmacal Co., Inc. on November 05, 2001. The current certification is valid through December 31, 2017.

How is this Hi-tech Pharmacal Co., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50383077215. 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)
50383-772-15
11-Digit CMS (5-4-2)
50383-0772-15

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