Fludarabine Phosphate Powder
NDC Package 51916-310-01

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.

Fludarabine Phosphate powders is a medication used to treat leukemia and other cancers. This formulation utilizes a powder delivery system. Marketed by Wuhan Biocause Pharmaceutical Development Co., Ltd, this product is identified by NDC 51916-310.

Identification & Billing

NDC Package Code
51916-310-01
Package Description
100 g in 1 BOTTLE, GLASS
Product Code
51916-310
11-Digit Billing Format
51916031001

Clinical Specifications

Proprietary Name
Fludarabine Phosphate
Non-Proprietary Name
Fludarabine Phosphate
Substance Name
Fludarabine Phosphate
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)
FLUDARABINE PHOSPHATE 100 g/100g
Usage Information
This medication is used to treat leukemia and other cancers. It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Wuhan Biocause Pharmaceutical Development Co., Ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-11-2005
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 51916-310-01 identifies a specific commercial package of 100 g in 1 bottle, glass of Fludarabine Phosphate (UNFINISHED drug), a bulk ingredient labeled by Wuhan Biocause Pharmaceutical Development Co., Ltd. This powder is formulated for use and contains fludarabine phosphate 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 Wuhan Biocause Pharmaceutical Development Co., Ltd on December 11, 2005. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat leukemia and other cancers. It works by slowing or stopping the growth of cancer cells.

How is this Wuhan Biocause Pharmaceutical Development Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51916031001. 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)
51916-310-01
11-Digit CMS (5-4-2)
51916-0310-01

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