Prolastin-c Kit
NDC Package 13533-706-22

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

Package Information

Prolastin-c (alpha-1-proteinase inhibitor (human)) kits is pROLASTIN-C is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency).PROLASTIN-C increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI. This formulation utilizes a kit delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 13533-706 and is authorized under FDA application BLA103174.

Identification & Billing

NDC Package Code
13533-706-22
Package Description
1 KIT in 1 CARTON * 20 mL in 1 VIAL, SINGLE-DOSE (13533-702-11) * 20 mL in 1 VIAL, SINGLE-DOSE (76297-002-22)
Product Code
13533-706
11-Digit Billing Format
13533070622
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prolastin-c
Non-Proprietary Name
Alpha-1-proteinase Inhibitor (human)
Dosage Form
Kit - A packaged collection of related material.
Usage Information
PROLASTIN-C is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency).PROLASTIN-C increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI. Limitations of UseThe effect of augmentation therapy with any Alpha1-PI, including PROLASTIN-C, on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C are not available.PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.

Regulatory & Marketing

Labeler Name
Grifols Usa, Llc
Product Type
Plasma Derivative
FDA Application #
BLA103174
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-02-1987
Listing Expiration
12-31-2026
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 13533-706-22 identifies a specific commercial package of 1 kit in 1 carton * 20 ml in 1 vial, single-dose (13533-702-11) * 20 ml in 1 vial, single-dose (76297-002-22) of Prolastin-c, a plasma derivative labeled by Grifols Usa, Llc. 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 Grifols Usa, Llc on December 02, 1987. The current certification is valid through December 31, 2026.

How is this Grifols Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13533070622. 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)
13533-706-22
11-Digit CMS (5-4-2)
13533-0706-22

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