Pramosone
NDC Package 0496-0729-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Pramosone is pramoxine is an anesthetic used on the skin to relieve minor pain, itching, and discomfort. Marketed by Ferndale Laboratories, Inc., this product is identified by NDC 0496-0729 and is authorized under FDA application ANDA085980.

Identification & Billing

NDC Package Code
0496-0729-04
Package Description
118 mL in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
00496072904
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 ML

Clinical Specifications

Proprietary Name
Pramosone
Dosage Form
-
Usage Information
Pramoxine is an anesthetic used on the skin to relieve minor pain, itching, and discomfort. Hydrocortisone is a corticosteroid that reduces redness, swelling, and itching. This combination medication is used to treat certain skin conditions such as eczema, rash, scrapes, insect bites, or minor burns. This combination product for the skin is available in different strengths and forms (e.g., creams, ointments, and lotions). The type of medication used depends on the location of your condition and the type of skin problem being treated. Creams are the most frequently used form. Lotions may be better suited to hairy areas. Ointments may be better suited for dry areas and when a stronger effect or skin protection is desired.

Regulatory & Marketing

Labeler Name
Ferndale Laboratories, Inc.
FDA Application #
ANDA085980
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-1977
End Marketing Date
03-31-2017
Listing Expiration
03-31-2017
Exclude Flag
D
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 (0496-0729). Click a package code to view its specific billing and regulatory data.

236 mL in 1 BOTTLE, PLASTIC
59 mL in 1 BOTTLE, PLASTIC
7.5 mL in 1 BOTTLE, PLASTIC

* 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 0496-0729-04 identifies a specific commercial package of 118 ml in 1 bottle, plastic of Pramosone, labeled by Ferndale Laboratories, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 118 billable units per package. 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 Ferndale Laboratories, Inc. on January 01, 1977. The current certification is valid through March 31, 2017.

What are the primary indications for this medication?

Pramoxine is an anesthetic used on the skin to relieve minor pain, itching, and discomfort. Hydrocortisone is a corticosteroid that reduces redness, swelling, and itching. This combination medication is used to treat certain skin conditions such as eczema, rash, scrapes, insect bites, or minor burns. This combination product for the skin is available in different strengths and forms (e.g., creams, ointments, and lotions). The type of medication used depends on the location of your condition and the type of skin problem being treated. Creams are the most frequently used form. Lotions may be better suited to hairy areas. Ointments may be better suited for dry areas and when a stronger effect or skin protection is desired.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00496072904. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 total billable units per package. 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)
0496-0729-04
11-Digit CMS (5-4-2)
00496-0729-04

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