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  5. NDC Package Code: 50633-120-11 Digifab

NDC Package 50633-120-11 Digifab

Ovine Digoxin Immune Fab Injection, Powder, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    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:
50633-120-11
Package Description:
1 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (50633-120-12)
Product Code:
50633-120
Proprietary Name:
Digifab
Non-Proprietary Name:
Ovine Digoxin Immune Fab
Substance Name:
Ovine Digoxin Immune Fab
Usage Information:
DIGIFAB is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose, including:Known suicidal or accidental consumption of fatal doses of digoxin: 10 mg or more of digoxin in healthy adults, or 4 mg (or more than 0.1 mg/kg) in healthy children, or ingestion of an amount that can cause steady state serum concentrations of ≥10 ng/mL; Chronic ingestions causing steady-state serum digoxin concentrations >6 ng/mL in adults or 4 ng/mL in children; Manifestations of life-threatening toxicity of digoxin overdose such as severe ventricular arrhythmias, progressive bradycardia, and second or third degree heart block not responsive to atropine, serum potassium levels exceeding 5.5 mEq/L in adults or 6 mEq/L in children with rapidly progressive signs and symptoms of digoxin toxicity.
11-Digit NDC Billing Format:
50633012011
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 349326 - digoxin immune fab (ovine) 40 MG Injection
  • RxCUI: 349326 - ovine digoxin immune fab 40 MG Injection
  • RxCUI: 404702 - DigiFab 40 MG Injection
  • RxCUI: 404702 - ovine digoxin immune fab 40 MG Injection [DigiFab]
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Btg International Inc.
    Dosage Form:
    Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • OVINE DIGOXIN IMMUNE FAB 40 mg/1
    • Pharmacologic Class(es):
  • Cardiac Glycoside - [EPC] (Established Pharmacologic Class)
  • Cardiac Glycosides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA103910
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    08-31-2001
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 50633-120-11 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    50633012011J1162Digoxin immune fab (ovine)PER VIAL1111

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50633-120-11?

    The NDC Packaged Code 50633-120-11 is assigned to a package of 1 vial, glass in 1 carton / 1 injection, powder, for solution in 1 vial, glass (50633-120-12) of Digifab, a plasma derivative labeled by Btg International Inc.. The product's dosage form is injection, powder, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 50633-120 included in the NDC Directory?

    Yes, Digifab with product code 50633-120 is active and included in the NDC Directory. The product was first marketed by Btg International Inc. on August 31, 2001 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 50633-120-11?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 50633-120-11?

    The 11-digit format is 50633012011. 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
    5-3-250633-120-115-4-250633-0120-11