NDC Package 28595-310-16 Histex-dm New Formulation

Dextromethorphan Hbr,Pseudoephedrine Hci,And Triprolidine Hci Syrup 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:

28595-310-16

Package Description:

473 mL in 1 BOTTLE

Product Code:

28595-310

Proprietary Name:

Histex-dm New Formulation

Non-Proprietary Name:

Dextromethorphan Hbr, Pseudoephedrine Hci, And Triprolidine Hci

Substance Name:

Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride; Triprolidine Hydrochloride

Usage Information:

Do not exceed recommended dosage.AGEDOSEAdults and Children 12 years of age and older:1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctorChildren 6 to under 12 years of age½ teaspoonful (2.5 mL) every 4 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours, or as directed by a doctor.Children under 6 years of ageConsult a doctor

11-Digit NDC Billing Format:

28595031016

Billing Unit:

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

NDC to RxNorm Crosswalk:

473 ML

NDC to RxNorm Crosswalk:

RxCUI: 2707699 - dextromethorphan HBr 20 MG / pseudoephedrine HCl 30 MG / triprolidine HCl 2.5 MG in 5 mL Oral Solution
RxCUI: 2707699 - dextromethorphan hydrobromide 4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML / triprolidine hydrochloride 0.5 MG/ML Oral Solution
RxCUI: 2707699 - dextromethorphan hydrobromide 20 MG / pseudoephedrine hydrochloride 30 MG / triprolidine hydrochloride 2.5 MG per 5 mL Oral Solution

Product Type:

Human Otc Drug

Labeler Name:

Allegis Pharmaceuticals, Llc

Dosage Form:

Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

M012

Marketing Category:

OTC MONOGRAPH DRUG -

Start Marketing Date:

03-10-2025

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

28595 - Allegis Pharmaceuticals, Llc
- 28595-310 - Histex-dm New Formulation
  - 28595-310-16 - 473 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 28595-310-16?

The NDC Packaged Code 28595-310-16 is assigned to a package of 473 ml in 1 bottle of Histex-dm New Formulation, a human over the counter drug labeled by Allegis Pharmaceuticals, Llc. The product's dosage form is syrup and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package.

Is NDC 28595-310 included in the NDC Directory?

Yes, Histex-dm New Formulation with product code 28595-310 is active and included in the NDC Directory. The product was first marketed by Allegis Pharmaceuticals, Llc on March 10, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 28595-310-16?

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 473.

What is the 11-digit format for NDC 28595-310-16?

The 11-digit format is 28595031016. 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	28595-310-16	5-4-2	28595-0310-16

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