Histex Pd Drops New Formulation Syrup
NDC Package 28595-809-30

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

Package Information

Histex Pd Drops New Formulation (triprolidine hydrochloride) syrups is do not exceed recommended dosage.use only the enclosed dropper.do not use enclosed dropper for any other drug products.AGEDOSEAdutls & Children 12 years of age or older:2 mL (2.5 mg) every 4 to 6 hours, not to exceed 8 mL (10 mg) in 24 hours or as directed by a doctor.Children 6 to under12 years of age:1 mL (1.25 mg) every 4 to 6 hours, not to exceed 4 mL (5 mg) in 24 hours or as directed by a doctor.Children under 6 years of age:Consult a docotor. This formulation utilizes a syrup delivery system. Marketed by Allegis Pharmaceuticals, Llc, this product is identified by NDC 28595-809 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
28595-809-30
Package Description
1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
Product Code
28595-809
11-Digit Billing Format
28595080930
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Histex Pd Drops New Formulation
Non-Proprietary Name
Triprolidine Hydrochloride
Substance Name
Triprolidine Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TRIPROLIDINE HYDROCHLORIDE 1.25 mg/mL
Usage Information
Do not exceed recommended dosage.use only the enclosed dropper.do not use enclosed dropper for any other drug products.AGEDOSEAdutls & Children 12 years of age or older:2 mL (2.5 mg) every 4 to 6 hours, not to exceed 8 mL (10 mg) in 24 hours or as directed by a doctor.Children 6 to under12 years of age:1 mL (1.25 mg) every 4 to 6 hours, not to exceed 4 mL (5 mg) in 24 hours or as directed by a doctor.Children under 6 years of age:Consult a docotor.

Regulatory & Marketing

Labeler Name
Allegis Pharmaceuticals, Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-13-2023
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 28595-809-30 identifies a specific commercial package of 1 bottle in 1 carton / 30 ml in 1 bottle of Histex Pd Drops New Formulation, a human over the counter drug labeled by Allegis Pharmaceuticals, Llc. This syrup is formulated for oral use and contains triprolidine 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 Allegis Pharmaceuticals, Llc on December 13, 2023. The current certification is valid through December 31, 2026.

How is this Allegis Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 28595080930. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
28595-809-30
11-Digit CMS (5-4-2)
28595-0809-30

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