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  5. NDC Package Code: 50633-310-11 Cyanokit

NDC Package 50633-310-11 Cyanokit

Hydroxocobalamin Injection, Powder, Lyophilized, 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:
50633-310-11
Package Description:
1 VIAL, GLASS in 1 CARTON / 250 mL in 1 VIAL, GLASS
Product Code:
50633-310
Proprietary Name:
Cyanokit
Non-Proprietary Name:
Hydroxocobalamin
Substance Name:
Hydroxocobalamin
Usage Information:
Hydroxocobalamin is a man-made injectable form of vitamin B12 used to treat low levels (deficiency) of this vitamin. Vitamin B12 helps your body use fat and carbohydrates for energy and make new protein. It is also important for normal blood, cells, and nerves. Most people get enough vitamin B12 in their diet, but a deficiency may occur in certain health conditions (e.g., poor nutrition, stomach/intestinal problems, infection, cancer). Serious vitamin B12 deficiency may result in anemia, stomach problems, and nerve damage.
11-Digit NDC Billing Format:
50633031011
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:
Product Type:
Human Prescription Drug
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.
Active Ingredient(s):
HYDROXOCOBALAMIN 5 g/250mL
Pharmacologic Class(es):
Antidote - [EPC] (Established Pharmacologic Class)
Sample Package:
No
FDA Application Number:
NDA022041
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
12-15-2021
Listing Expiration Date:
12-31-2025
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 50633-310-11 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
50633031011J3424Inj hydroxocobalamin iv 25mg25 MG11200200

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 50633-310-11?

The NDC Packaged Code 50633-310-11 is assigned to a package of 1 vial, glass in 1 carton / 250 ml in 1 vial, glass of Cyanokit, a human prescription drug 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 1 billable units per package.

Is NDC 50633-310 included in the NDC Directory?

Yes, Cyanokit with product code 50633-310 is active and included in the NDC Directory. The product was first marketed by Btg International Inc. on December 15, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 50633-310-11?

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 50633-310-11?

The 11-digit format is 50633031011. 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
5-3-250633-310-115-4-250633-0310-11