Hydrocodone Bitartrate Powder
NDC Package 51927-0331-0

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.

Hydrocodone Bitartrate powders is hydrocodone is used to help relieve severe ongoing pain. This formulation utilizes a powder delivery system. Marketed by Professional Compounding Centers Of America, this product is identified by NDC 51927-0331.

Identification & Billing

NDC Package Code
51927-0331-0
Package Description
1 kg in 1 BOTTLE
Product Code
51927-0331
11-Digit Billing Format
51927033100

Clinical Specifications

Proprietary Name
Hydrocodone Bitartrate
Non-Proprietary Name
Hydrocodone Bitartrate
Substance Name
Hydrocodone Bitartrate
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)
HYDROCODONE BITARTRATE 1 kg/kg
Usage Information
Hydrocodone is used to help relieve severe ongoing pain. Hydrocodone belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use the extended-release form of hydrocodone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Professional Compounding Centers Of America
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
04-05-2024
Listing Expiration
12-31-2027
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 51927-0331-0 identifies a specific commercial package of 1 kg in 1 bottle of Hydrocodone Bitartrate (UNFINISHED drug), a bulk ingredient labeled by Professional Compounding Centers Of America. This powder is formulated for use and contains hydrocodone bitartrate 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 Professional Compounding Centers Of America on April 05, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Hydrocodone is used to help relieve severe ongoing pain. Hydrocodone belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use the extended-release form of hydrocodone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

How is this Professional Compounding Centers Of America product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51927033100. 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)
51927-0331-0
11-Digit CMS (5-4-2)
51927-0331-00

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