Alpha-lipoic Acid Powder
NDC Package 10695-310-50

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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.

Alpha-lipoic Acid powders is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a powder delivery system. Marketed by Willow Birch Pharma, Llc, this product is identified by NDC 10695-310.

Identification & Billing

NDC Package Code
10695-310-50
Package Description
5 kg in 1 CONTAINER
Product Code
10695-310
11-Digit Billing Format
10695031050

Clinical Specifications

Proprietary Name
Alpha-lipoic Acid
Non-Proprietary Name
Alpha-lipoic Acid
Substance Name
.alpha.-lipoic Acid
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)

Regulatory & Marketing

Labeler Name
Willow Birch Pharma, Llc
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
05-12-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10695-310). Click a package code to view its specific billing and regulatory data.

10695-310-70
25 kg in 1 CONTAINER

* 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 10695-310-50 identifies a specific commercial package of 5 kg in 1 container of Alpha-lipoic Acid (UNFINISHED drug), a bulk ingredient labeled by Willow Birch Pharma, Llc. This powder is formulated for use and contains .alpha.-lipoic acid 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 Willow Birch Pharma, Llc on May 12, 2025. The current certification is valid through December 31, 2026.

How is this Willow Birch Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10695031050. 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)
10695-310-50
11-Digit CMS (5-4-2)
10695-0310-50

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