NDC Package 13533-703-10 Prolastin-c

Alpha-1-proteinase Inhibitor (human) Kit - View Billable Units, 11-Digit Format, RxNorm

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:
Package Description:
1 KIT in 1 CARTON * 20 mL in 1 VIAL, SINGLE-DOSE (13533-702-11) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-200-20)
Product Code:
Proprietary Name:
Non-Proprietary Name:
Alpha-1-proteinase Inhibitor (human)
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.
11-Digit NDC Billing Format:
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
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:
    Kit - A packaged collection of related material.
    Sample Package:
    FDA Application Number:
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    Listing Expiration Date:
    Exclude Flag:
    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.

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    Frequently Asked Questions

    What is NDC 13533-703-10?

    The NDC Packaged Code 13533-703-10 is assigned to a package of 1 kit in 1 carton * 20 ml in 1 vial, single-dose (13533-702-11) * 20 ml in 1 vial, single-dose (13533-200-20) of Prolastin-c, a plasma derivative labeled by Grifols Usa, Llc. The product's dosage form is kit and is administered via form.

    Is NDC 13533-703 included in the NDC Directory?

    Yes, Prolastin-c with product code 13533-703 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 NDC billing unit for package 13533-703-10?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 13533-703-10?

    The 11-digit format is 13533070310. 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