NDC Package 58809-770-08 Childrens Pediaclear 8

Pyrilamine Maleate Liquid Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

58809-770-08

Package Description:

237 mL in 1 BOTTLE

Product Code:

58809-770

Proprietary Name:

Childrens Pediaclear 8

Non-Proprietary Name:

Pyrilamine Maleate

Substance Name:

Pyrilamine Maleate

Usage Information:

■ use only with enclosed dose cup and keep with product■ mL= milliliter■ professional labeling: for use under guidance of health professional only children 6 to under 12 years of age: 30 mL (2 dose cups) every 6 to 8 hours, not to exceed 4 doses in 24 hours. children 2 to under 6 years of age:15 mL (1 dose cup) every 6 to 8 hours, not to exceed 4 doses in 24 hours.

11-Digit NDC Billing Format:

58809077008

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

237 ML

NDC to RxNorm Crosswalk:

RxCUI: 2178279 - pyrilamine maleate 12.5 MG in 15 mL Oral Solution

RxCUI: 2178279 - pyrilamine maleate 0.833 MG/ML Oral Solution

RxCUI: 2178279 - pyrilamine maleate 12.5 MG per 15 mL Oral Solution

RxCUI: 2178281 - PediaClear 12.5 MG in 15 mL Oral Solution

RxCUI: 2178281 - pyrilamine maleate 0.833 MG/ML Oral Solution [Pediaclear]

Product Type:

Human Otc Drug

Labeler Name:

Gm Pharmaceuticals, Inc

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(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

PYRILAMINE MALEATE 12.5 mg/15mL

Sample Package:

FDA Application Number:

part341

Marketing Category:

OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Start Marketing Date:

08-19-2019

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

58809 - Gm Pharmaceuticals, Inc
- 58809-770 - Childrens Pediaclear 8
  - 58809-770-08 - 237 mL in 1 BOTTLE

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 disclaimer below.

Frequently Asked Questions

What is NDC 58809-770-08?

The NDC Packaged Code 58809-770-08 is assigned to a package of 237 ml in 1 bottle of Childrens Pediaclear 8, a human over the counter drug labeled by Gm Pharmaceuticals, Inc. The product's dosage form is liquid and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 237 billable units per package.

Is NDC 58809-770 included in the NDC Directory?

Yes, Childrens Pediaclear 8 with product code 58809-770 is active and included in the NDC Directory. The product was first marketed by Gm Pharmaceuticals, Inc on August 19, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 58809-770-08?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 237.

What is the 11-digit format for NDC 58809-770-08?

The 11-digit format is 58809077008. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	58809-770-08	5-4-2	58809-0770-08

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