Bylvay Capsule, Coated Pellets
NDC Package 74528-040-01

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

Package Information

Bylvay (odevixibat) capsules is bYLVAY is indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). This formulation utilizes a capsule, coated pellets delivery system. Marketed by Albireo Pharma, Inc., this product is identified by NDC 74528-040 and is authorized under FDA application NDA215498.

Identification & Billing

NDC Package Code
74528-040-01
Package Description
1 BOTTLE in 1 CARTON / 30 CAPSULE, COATED PELLETS in 1 BOTTLE
Product Code
74528-040
11-Digit Billing Format
74528004001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bylvay
Non-Proprietary Name
Odevixibat
Substance Name
Odevixibat
Dosage Form
Capsule, Coated Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which varying amounts of coating have been applied.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ODEVIXIBAT 400 ug/1
Pharmacologic Class
Usage Information
BYLVAY is indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).

Regulatory & Marketing

Labeler Name
Albireo Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA215498
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-20-2021
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 74528-040-01 identifies a specific commercial package of 1 bottle in 1 carton / 30 capsule, coated pellets in 1 bottle of Bylvay, a human prescription drug labeled by Albireo Pharma, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This capsule, coated pellets is formulated for oral use and contains odevixibat 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 Albireo Pharma, Inc. on July 20, 2021. The current certification is valid through December 31, 2027.

How is this Albireo Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 74528004001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
74528-040-01
11-Digit CMS (5-4-2)
74528-0040-01

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