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  5. NDC Package Code: 13533-705-31 Prolastin-c Liquid

NDC Package 13533-705-31 Prolastin-c Liquid

Alpha1-proteinase Inhibitor (human) Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
13533-705-31
Package Description:
1 VIAL in 1 CARTON / 10 mL in 1 VIAL (13533-705-32)
Product Code:
13533-705
Proprietary Name:
Prolastin-c Liquid
Non-Proprietary Name:
Alpha1-proteinase Inhibitor (human)
Substance Name:
.alpha.1-proteinase Inhibitor Human
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.
11-Digit NDC Billing Format:
13533070531
NDC to RxNorm Crosswalk:
  • RxCUI: 1661208 - alpha 1-proteinase inhibitor, human 1 MG Injection
  • RxCUI: 1661220 - Prolastin-C 1 MG Injection
  • RxCUI: 1661220 - alpha 1-proteinase inhibitor, human 1 MG Injection [Prolastin]
  • RxCUI: 1661220 - Prolastin 1 MG Injection
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Grifols Usa, Llc
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • .ALPHA.1-PROTEINASE INHIBITOR HUMAN 1000 mg/20mL
    • Pharmacologic Class(es):
  • Human alpha-1 Proteinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Trypsin Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    BLA103174
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-02-1987
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    13533-705-011 VIAL in 1 CARTON / 20 mL in 1 VIAL (13533-705-11)
    13533-705-511 VIAL in 1 CARTON / 80 mL in 1 VIAL (13533-705-52)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 13533-705-31?

    The NDC Packaged Code 13533-705-31 is assigned to a package of 1 vial in 1 carton / 10 ml in 1 vial (13533-705-32) of Prolastin-c Liquid, a plasma derivative labeled by Grifols Usa, Llc. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 13533-705 included in the NDC Directory?

    Yes, Prolastin-c Liquid with product code 13533-705 is active and included in the NDC Directory. The product was first marketed by Grifols Usa, Llc on December 02, 1987 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 13533-705-31?

    The 11-digit format is 13533070531. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-213533-705-315-4-213533-0705-31