Childrens Allergy Suspension
NDC Package 61269-527-94

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

Package Information

Childrens Allergy (fexofenadine hydrochloride) suspension is shake well before usinguse only with enclosed dosing cupNote: mL = millilitersadults and children 12 years of age and overtake 10 mL every 12 hours; do not take more than 20 mL in 24 hourschildren 2 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hourschildren under 2 years of ageask a doctoradults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor. This formulation utilizes a suspension delivery system. Marketed by H2-pharma, Llc, this product is identified by NDC 61269-527 and is authorized under FDA application ANDA203330.

Identification & Billing

NDC Package Code
61269-527-94
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
61269-527
11-Digit Billing Format
61269052794
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Childrens Allergy
Non-Proprietary Name
Fexofenadine Hydrochloride
Substance Name
Fexofenadine Hydrochloride
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FEXOFENADINE HYDROCHLORIDE 30 mg/5mL
Pharmacologic Class
Usage Information
Shake well before usinguse only with enclosed dosing cupNote: mL = millilitersadults and children 12 years of age and overtake 10 mL every 12 hours; do not take more than 20 mL in 24 hourschildren 2 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hourschildren under 2 years of ageask a doctoradults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
H2-pharma, Llc
Product Type
Human Otc Drug
FDA Application #
ANDA203330
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-18-2022
End Marketing Date
06-30-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61269-527). Click a package code to view its specific billing and regulatory data.

61269-527-98
1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE

* 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 61269-527-94 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Childrens Allergy, a human over the counter drug labeled by H2-pharma, Llc. This suspension is formulated for oral use and contains fexofenadine 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 H2-pharma, Llc on July 18, 2022.

How is this H2-pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61269052794. 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)
61269-527-94
11-Digit CMS (5-4-2)
61269-0527-94

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