Rynex Pe Liquid
NDC Package 0485-0202-16

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

Package Information

Rynex Pe (brompheniramine maleate and phenylephrine hcl) liquids is do not exceed recommended dosage.Adults and children 12 years of age and over:4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours, or as directed by a doctor.Children 6 to under 12 years of age:2 teaspoonfuls(10 mL) every 4 hours, not to exceed 1 teaspoonfuls in 24 hours, or as directed by a doctor.Children 2 to under 6 years of age:1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.Children under 2 years of age:Consult a doctor. This formulation utilizes a liquid delivery system. Marketed by Edwards Pharmaceuticals, Inc., this product is identified by NDC 0485-0202 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0485-0202-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
0485-0202
11-Digit Billing Format
00485020216
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk
  • RxCUI: 1053258 - brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1053258 - brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1053258 - brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Elixir
  • RxCUI: 1053258 - brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution
  • RxCUI: 1053258 - brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution

Clinical Specifications

Proprietary Name
Rynex Pe
Non-Proprietary Name
Brompheniramine Maleate And Phenylephrine Hcl
Substance Name
Brompheniramine Maleate; Phenylephrine Hydrochloride
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)
Pharmacologic Class
Usage Information
Do not exceed recommended dosage.Adults and children 12 years of age and over:4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours, or as directed by a doctor.Children 6 to under 12 years of age:2 teaspoonfuls(10 mL) every 4 hours, not to exceed 1 teaspoonfuls in 24 hours, or as directed by a doctor.Children 2 to under 6 years of age:1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.Children under 2 years of age:Consult a doctor.

Regulatory & Marketing

Labeler Name
Edwards Pharmaceuticals, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-07-2011
Listing Expiration
12-31-2027
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 0485-0202-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Rynex Pe, a human over the counter drug labeled by Edwards Pharmaceuticals, Inc.. This liquid is formulated for oral use and contains brompheniramine maleate; phenylephrine hydrochloride 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, 2011. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00485020216. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
0485-0202-16
11-Digit CMS (5-4-2)
00485-0202-16

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