Alkindi Granule
NDC Package 71863-110-50

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

Package Information

Alkindi (hydrocortisone) granules is a medication used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). This formulation utilizes a granule delivery system. Marketed by Eton Pharmaceuticals, Inc., this product is identified by NDC 71863-110 and is authorized under FDA application NDA213876.

Identification & Billing

NDC Package Code
71863-110-50
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 50 GRANULE in 1 BOTTLE, PLASTIC
Product Code
71863-110
11-Digit Billing Format
71863011050
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Alkindi Sprinkle
Non-Proprietary Name
Hydrocortisone
Substance Name
Hydrocortisone
Dosage Form
Granule - A small particle or grain.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYDROCORTISONE 1 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

Regulatory & Marketing

Labeler Name
Eton Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA213876
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-29-2020
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 71863-110-50 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 50 granule in 1 bottle, plastic of Alkindi Sprinkle, a human prescription drug labeled by Eton Pharmaceuticals, Inc.. This granule is formulated for oral use and contains hydrocortisone 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 Eton Pharmaceuticals, Inc. on September 29, 2020. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71863011050. 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)
71863-110-50
11-Digit CMS (5-4-2)
71863-0110-50

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