Hydroxocobalamin Powder
NDC Package 50396-7902-0

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Hydroxocobalamin powders is hydroxocobalamin is a man-made injectable form of vitamin B12 used to treat low levels (deficiency) of this vitamin. This formulation utilizes a powder delivery system. Marketed by Sanofi Winthrop Industrie, this product is identified by NDC 50396-7902.

Identification & Billing

NDC Package Code
50396-7902-0
Package Description
100 g in 1 CONTAINER
Product Code
50396-7902
11-Digit Billing Format
50396790200

Clinical Specifications

Proprietary Name
Hydroxocobalamin
Non-Proprietary Name
Hydroxocobalamin
Substance Name
Hydroxocobalamin
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
HYDROXOCOBALAMIN 1 g/g
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
Sanofi Winthrop Industrie
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-01-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50396-7902-0 identifies a specific commercial package of 100 g in 1 container of Hydroxocobalamin (UNFINISHED drug), a bulk ingredient labeled by Sanofi Winthrop Industrie. This powder is formulated for 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 Sanofi Winthrop Industrie on February 01, 2015. 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 Sanofi Winthrop Industrie product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50396790200. 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 (5-4-1)
50396-7902-0
11-Digit CMS (5-4-2)
50396-7902-00

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