Prolastin-c
NDC Package 13533-701-01

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

Package Information

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

Prolastin-c is a . Marketed by Grifols Usa, Llc, this product is identified by NDC 13533-701 and is authorized under FDA application BLA103174.

Identification & Billing

NDC Package Code
13533-701-01
Package Description
1 KIT in 1 CARTON * 20 mL in 1 VIAL, SINGLE-DOSE (13533-702-11) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-100-70)
Product Code
13533-701
11-Digit Billing Format
13533070101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Prolastin-c
Dosage Form
-

Regulatory & Marketing

Labeler Name
Grifols Usa, Llc
FDA Application #
BLA103174
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-02-1987
End Marketing Date
03-07-2022
Listing Expiration
03-07-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 13533-701-01 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 (13533-100-70) of Prolastin-c, labeled by Grifols Usa, Llc. 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 Grifols Usa, Llc on December 02, 1987. The current certification is valid through March 07, 2022.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13533070101. 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)
13533-701-01
11-Digit CMS (5-4-2)
13533-0701-01

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