Orladeyo Capsule
NDC Package 72769-101-01

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

Package Information

Orladeyo (berotralstat hydrochloride) capsules is oRLADEYO™ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older. This formulation utilizes a capsule delivery system. Marketed by Biocryst Pharmaceuticals, Inc., this product is identified by NDC 72769-101 and is authorized under FDA application NDA214094.

Identification & Billing

NDC Package Code
72769-101-01
Package Description
4 DOSE PACK in 1 CARTON / 1 BLISTER PACK in 1 DOSE PACK / 7 CAPSULE in 1 BLISTER PACK
Product Code
72769-101
11-Digit Billing Format
72769010101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Orladeyo
Non-Proprietary Name
Berotralstat Hydrochloride
Substance Name
Berotralstat Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BEROTRALSTAT HYDROCHLORIDE 150 mg/1
Pharmacologic Class
Usage Information
ORLADEYO™ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older.

Regulatory & Marketing

Labeler Name
Biocryst Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214094
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-04-2020
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 72769-101-01 identifies a specific commercial package of 4 dose pack in 1 carton / 1 blister pack in 1 dose pack / 7 capsule in 1 blister pack of Orladeyo, a human prescription drug labeled by Biocryst Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This capsule is formulated for oral use and contains berotralstat 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 Biocryst Pharmaceuticals, Inc. on December 04, 2020. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72769010101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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 (5-3-2)
72769-101-01
11-Digit CMS (5-4-2)
72769-0101-01

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