.alpha.1-proteinase Inhibitor Human Injection
NDC Package 63552-210-00

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

.alpha.1-proteinase Inhibitor Human injection is a drug for further processing. This formulation utilizes a injection delivery system. Marketed by Patheon Manufacturing Services Llc, this product is identified by NDC 63552-210.

Identification & Billing

NDC Package Code
63552-210-00
Package Description
20 VIAL, SINGLE-DOSE in 1 CASE / 76 mL in 1 VIAL, SINGLE-DOSE
Product Code
63552-210
11-Digit Billing Format
63552021000

Clinical Specifications

Proprietary Name
.alpha.1-proteinase Inhibitor Human
Non-Proprietary Name
.alpha.1-proteinase Inhibitor Human
Substance Name
.alpha.1-proteinase Inhibitor Human
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Active Ingredient(s)
.ALPHA.1-PROTEINASE INHIBITOR HUMAN 4000 mg/76mL

Regulatory & Marketing

Labeler Name
Patheon Manufacturing Services Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-17-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 63552-210-00 identifies a specific commercial package of 20 vial, single-dose in 1 case / 76 ml in 1 vial, single-dose of .alpha.1-proteinase Inhibitor Human (UNFINISHED drug), drug for further processing labeled by Patheon Manufacturing Services Llc. This injection is formulated for use and contains .alpha.1-proteinase inhibitor human 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 Patheon Manufacturing Services Llc on January 17, 2025. The current certification is valid through December 31, 2026.

How is this Patheon Manufacturing Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63552021000. 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)
63552-210-00
11-Digit CMS (5-4-2)
63552-0210-00

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