NDC Package 50633-110-12 Crofab

Ovine Crotalidae Venoms Immune Fab Injection, Powder, Lyophilized, For Solution - 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:
50633-110-12
Package Description:
2 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (50633-110-11)
Product Code:
Proprietary Name:
Crofab
Non-Proprietary Name:
Ovine Crotalidae Venoms Immune Fab
Substance Name:
Agkistrodon Piscivorus Immune Fab Antivenin (ovine); Crotalus Adamanteus Immune Fab Antivenin (ovine); Crotalus Atrox Immune Fab Antivenin (ovine); Crotalus Scutulatus Immune Fab Antivenin (ovine)
Usage Information:
CROFAB is indicated for the management of adult and pediatric patients with North American crotalid envenomation (see Table 5 in Clinical Studies section (14) for definitions). The term crotalid is used to describe the Crotalinae subfamily (formerly known as Crotalidae) of venomous snakes which includes rattlesnakes, copperheads and cottonmouths/water moccasins.
11-Digit NDC Billing Format:
50633011012
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
2 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 885192 - Crotalidae polyvalent immune Fab (ovine) (equivalent to 1 GM total protein) Injection
  • RxCUI: 885192 - Agkistrodon piscivorus antivenin 780 UNT / Crotalus adamanteus antivenin 420 UNT / Crotalus atrox antivenin 1270 UNT / Crotalus scutulatus antivenin 5570 UNT Injection
  • RxCUI: 885192 - Agkistrodon piscivorus antivenin / Crotalus adamanteus antivenin / Crotalus atrox antivenin / Crotalus scutulatus antivenin (equivalent to 1 GM total protein) Injection
  • RxCUI: 885195 - CroFab (Crotalidae polyvalent immune fab (ovine) equivalent to 1 GM total protein) Injection
  • RxCUI: 885195 - Agkistrodon piscivorus antivenin 780 UNT / Crotalus adamanteus antivenin 420 UNT / Crotalus atrox antivenin 1270 UNT / Crotalus scutulatus antivenin 5570 UNT Injection [CroFab]
  • Product Type:
    Plasma Derivative
    Labeler Name:
    Btg International Inc.
    Dosage Form:
    Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    BLA103788
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    02-10-2000
    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.

    Frequently Asked Questions

    What is NDC 50633-110-12?

    The NDC Packaged Code 50633-110-12 is assigned to a package of 2 vial, glass in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, glass (50633-110-11) of Crofab, a plasma derivative labeled by Btg International Inc.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package.

    Is NDC 50633-110 included in the NDC Directory?

    Yes, Crofab with product code 50633-110 is active and included in the NDC Directory. The product was first marketed by Btg International Inc. on February 10, 2000 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 50633-110-12?

    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 2.

    What is the 11-digit format for NDC 50633-110-12?

    The 11-digit format is 50633011012. 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
    5-3-250633-110-125-4-250633-0110-12