Ed Apap Liquid
NDC Package 0485-0057-08

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

Package Information

Ed Apap (acetaminophen) liquids is a medication used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever. This formulation utilizes a liquid delivery system. Marketed by Edwards Pharmaceuticals, Inc., this product is identified by NDC 0485-0057 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
0485-0057-08
Package Description
236 mL in 1 BOTTLE, PLASTIC
Product Code
0485-0057
11-Digit Billing Format
00485005708
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
236 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ed Apap
Non-Proprietary Name
Acetaminophen
Substance Name
Acetaminophen
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ACETAMINOPHEN 160 mg/5mL
Usage Information
This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Regulatory & Marketing

Labeler Name
Edwards Pharmaceuticals, Inc.
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-07-2012
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 0485-0057-08 identifies a specific commercial package of 236 ml in 1 bottle, plastic of Ed Apap, a human over the counter drug labeled by Edwards Pharmaceuticals, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 236 billable units per package. This liquid is formulated for oral use and contains acetaminophen 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 Edwards Pharmaceuticals, Inc. on March 07, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00485005708. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 236 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)
0485-0057-08
11-Digit CMS (5-4-2)
00485-0057-08

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