Prolastin-c Liquid Injection, Solution
NDC Package 13533-705-01

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

Package Information

Prolastin-c Liquid (alpha1-proteinase inhibitor (human)) injection is pROLASTIN®-C LIQUID 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).Limitations of UseThe effect of augmentation therapy with any Alpha1-PI, including PROLASTIN-C LIQUID, 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 LIQUID are not available.PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established. This formulation utilizes a injection, solution delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 13533-705 and is authorized under FDA application BLA103174.

Identification & Billing

NDC Package Code
13533-705-01
Package Description
1 VIAL in 1 CARTON / 20 mL in 1 VIAL (13533-705-11)
Product Code
13533-705
11-Digit Billing Format
13533070501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prolastin-c Liquid
Non-Proprietary Name
Alpha1-proteinase Inhibitor (human)
Substance Name
.alpha.1-proteinase Inhibitor Human
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
.ALPHA.1-PROTEINASE INHIBITOR HUMAN 1000 mg/20mL
Pharmacologic Class
Usage Information
PROLASTIN®-C LIQUID 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).Limitations of UseThe effect of augmentation therapy with any Alpha1-PI, including PROLASTIN-C LIQUID, 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 LIQUID are not available.PROLASTIN-C LIQUID 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.

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.

J0256
Source: PDAC
INJECTION, ALPHA 1 PROTEINASE INHIBITOR (HUMAN), NOT OTHERWISE SPECIFIED, 10 MG
HCPCS Dosage 10 MG
Units / Pkg

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (13533-705). Click a package code to view its specific billing and regulatory data.

13533-705-31
1 VIAL in 1 CARTON / 10 mL in 1 VIAL (13533-705-32)
13533-705-51
1 VIAL in 1 CARTON / 80 mL in 1 VIAL (13533-705-52)

* 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 13533-705-01 identifies a specific commercial package of 1 vial in 1 carton / 20 ml in 1 vial (13533-705-11) of Prolastin-c Liquid, a plasma derivative labeled by Grifols Usa, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, solution is formulated for intravenous 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 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: 13533070501. 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)
13533-705-01
11-Digit CMS (5-4-2)
13533-0705-01

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