NDC Package 61953-0012-1 Vistaseal

Human Fibrinogen,Human Thrombin 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:
61953-0012-1
Package Description:
1 KIT in 1 PACKAGE, COMBINATION * 2 mL in 1 SYRINGE, GLASS * 2 mL in 1 SYRINGE, GLASS
Product Code:
Proprietary Name:
Vistaseal
Non-Proprietary Name:
Human Fibrinogen, Human Thrombin
Usage Information:
VISTASEAL is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.
11-Digit NDC Billing Format:
61953001201
NDC to RxNorm Crosswalk:
  • RxCUI: 2264366 - fibrin sealant (thrombin 500 UNT/mL, human) topical solution 2 mL Prefilled Syringe, frozen
  • RxCUI: 2264366 - 2 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe
  • RxCUI: 2264366 - fibrin sealant (thrombin 500 UNT/ML, human) topical solution 2 ML Prefilled Syringe, frozen
  • RxCUI: 2264371 - VistaSeal (Frozen) fibrin sealant (human) topical solution 2 mL Prefilled Syringe
  • RxCUI: 2264371 - 2 ML fibrinogen, human 80 MG/ML / thrombin, human 500 UNT/ML Prefilled Syringe [Vistaseal]
  • Product Type:
    Plasma Derivative
    Labeler Name:
    Grifols Usa, Llc
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    BLA125640
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-01-2019
    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.

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    Frequently Asked Questions

    What is NDC 61953-0012-1?

    The NDC Packaged Code 61953-0012-1 is assigned to a package of 1 kit in 1 package, combination * 2 ml in 1 syringe, glass * 2 ml in 1 syringe, glass of Vistaseal, a plasma derivative labeled by Grifols Usa, Llc. The product's dosage form is kit and is administered via form.

    Is NDC 61953-0012 included in the NDC Directory?

    Yes, Vistaseal with product code 61953-0012 is active and included in the NDC Directory. The product was first marketed by Grifols Usa, Llc on November 01, 2019 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 61953-0012-1?

    The 11-digit format is 61953001201. 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 5-4-1 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
    5-4-161953-0012-15-4-261953-0012-01