Roctavian
NDC Package 68135-927-48

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Roctavian is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test. Marketed by Biomarin Pharmaceutical Inc., this product is identified by NDC 68135-927 and is authorized under FDA application BLA125720.

Identification & Billing

NDC Package Code
68135-927-48
Package Description
1 VIAL in 1 CARTON / 8 mL in 1 VIAL (68135-927-01)
Product Code
68135-927
11-Digit Billing Format
68135092748
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Roctavian
Dosage Form
-
Usage Information
ROCTAVIAN is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test.

Regulatory & Marketing

Labeler Name
Biomarin Pharmaceutical Inc.
FDA Application #
BLA125720
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-29-2023
End Marketing Date
05-29-2026
Listing Expiration
05-29-2026
Exclude Flag
D
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1412
Source: OPPS
Inj roctavian ml 2x10^13vc g
HCPCS Dosage 1 ML
Units / Pkg 8

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 68135-927-48 identifies a specific commercial package of 1 vial in 1 carton / 8 ml in 1 vial (68135-927-01) of Roctavian, labeled by Biomarin Pharmaceutical Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Biomarin Pharmaceutical Inc. on June 29, 2023. The current certification is valid through May 29, 2026.

How is this Biomarin Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68135092748. 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)
68135-927-48
11-Digit CMS (5-4-2)
68135-0927-48

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