Activase Kit
NDC Package 50242-044-13

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

Activase (alteplase) kits is activase is indicated for the treatment of acute ischemic stroke.Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment [see Contraindications (4.1)]. This formulation utilizes a kit delivery system. Marketed by Genentech, Inc., this product is identified by NDC 50242-044 and is authorized under FDA application BLA103172.

Identification & Billing

NDC Package Code
50242-044-13
Package Description
1 KIT in 1 CARTON * 50 mL in 1 VIAL, SINGLE-USE * 50 mL in 1 VIAL, SINGLE-USE
Product Code
50242-044
11-Digit Billing Format
50242004413
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Activase
Non-Proprietary Name
Alteplase
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Activase is indicated for the treatment of acute ischemic stroke.Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment [see Contraindications (4.1)]. Initiate treatment as soon as possible but within 3 hours after symptom onset.

Regulatory & Marketing

Labeler Name
Genentech, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA103172
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-13-1987
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.

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.

J2997
Source: ASP
Alteplase recombinant
HCPCS Dosage 1 MG
Units / Pkg 50

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 50242-044-13 identifies a specific commercial package of 1 kit in 1 carton * 50 ml in 1 vial, single-use * 50 ml in 1 vial, single-use of Activase, a human prescription drug labeled by Genentech, Inc.. This kit is formulated for use and contains 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 Genentech, Inc. on November 13, 1987. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50242004413. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
50242-044-13
11-Digit CMS (5-4-2)
50242-0044-13

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