Cyanokit Injection, Powder, Lyophilized, For Solution
NDC Package 50633-310-11

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Cyanokit (hydroxocobalamin) injection is hydroxocobalamin is a man-made injectable form of vitamin B12 used to treat low levels (deficiency) of this vitamin. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Btg International Inc., this product is identified by NDC 50633-310 and is authorized under FDA application NDA022041.

Identification & Billing

NDC Package Code
50633-310-11
Package Description
1 VIAL, GLASS in 1 CARTON / 250 mL in 1 VIAL, GLASS
Product Code
50633-310
11-Digit Billing Format
50633031011
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cyanokit
Non-Proprietary Name
Hydroxocobalamin
Substance Name
Hydroxocobalamin
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
HYDROXOCOBALAMIN 5 g/250mL
Pharmacologic Class
Antidote - [EPC] (Established Pharmacologic Class)
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.

Regulatory & Marketing

Labeler Name
Btg International Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022041
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-15-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3424
Source: OPPS
Inj hydroxocobalamin iv 25mg
HCPCS Dosage 25 MG
Units / Pkg 200

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50633-310-11 identifies a specific commercial 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.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains hydroxocobalamin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Btg International Inc. on December 15, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Btg International Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50633031011. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50633-310-11
11-Digit CMS (5-4-2)
50633-0310-11

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.