Childrens Accudial
NDC Package 45014-137-04

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.

Childrens Accudial is this product does not contain directions or complete warnings for adult use.shake well before usingif needed, repeat dose every 4 hoursdo not use more than 5 times in 24 hourswhen weight is known: use the rotating bottle label to find the child's weight and read the correct dose. Marketed by Accudial Pharmaceutical, Inc., this product is identified by NDC 45014-137 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
45014-137-04
Package Description
118 mL in 1 BOTTLE
Product Code
45014-137
11-Digit Billing Format
45014013704
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Childrens Accudial Pain Reliever/ Fever Reducer
Dosage Form
-
Usage Information
This product does not contain directions or complete warnings for adult use.shake well before usingif needed, repeat dose every 4 hoursdo not use more than 5 times in 24 hourswhen weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose.when weight is unknown: use the age chart on the rotating label.use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing deviceAge (yr)Dose (mL or tsp)tsp. = teaspoonmL = milliliterunder 6 mos.ask a doctor6 mos. to under 22.5 mL or ½ tsp.2 to under 45 mL or 1 tsp.4 to under 67.5 mL or 1½ tsp.6 to under 910 mL or 2 tsp.9 to under 1112.5 mL or 2½ tsp.11 to under 1215 mL or 3 tsp.or as directed by a doctorAsk a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.

Regulatory & Marketing

Labeler Name
Accudial Pharmaceutical, Inc.
FDA Application #
part343
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
04-25-2012
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 45014-137-04 identifies a specific commercial package of 118 ml in 1 bottle of Childrens Accudial Pain Reliever/ Fever Reducer, labeled by Accudial Pharmaceutical, 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 Accudial Pharmaceutical, Inc. on April 25, 2012. The current certification is valid through December 31, 2017.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45014013704. 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)
45014-137-04
11-Digit CMS (5-4-2)
45014-0137-04

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