Penicillamine Powder
NDC Package 76339-159-00

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.

Penicillamine powders is a medication used to treat rheumatoid arthritis, Wilson's disease (a condition in which high levels of copper in the body cause damage to the liver, brain, and other organs), and a certain disorder which causes kidney stones (cystinuria). This formulation utilizes a powder delivery system. Marketed by Apothecon Pharmaceuticals Pvt Ltd, this product is identified by NDC 76339-159.

Identification & Billing

NDC Package Code
76339-159-00
Package Description
1 BAG in 1 DRUM / 1 BAG in 1 BAG / .999 kg in 1 BAG
Product Code
76339-159
11-Digit Billing Format
76339015900

Clinical Specifications

Proprietary Name
Penicillamine
Non-Proprietary Name
Penicillamine
Substance Name
Penicillamine
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)
PENICILLAMINE 9.999 kg/9.999kg
Usage Information
This medication is used to treat rheumatoid arthritis, Wilson's disease (a condition in which high levels of copper in the body cause damage to the liver, brain, and other organs), and a certain disorder which causes kidney stones (cystinuria). For the treatment of rheumatoid arthritis, penicillamine is known as a disease-modifying antirheumatic drug (DMARD). It helps to decrease pain/tenderness/swelling in the joints. For the treatment of Wilson's disease, penicillamine binds to copper and helps it to be removed from the body. Decreasing copper levels helps to improve liver function and the mental/mood/nerve problems (such as confusion, difficulty speaking/walking) caused by the disease. For the treatment of cystinuria, penicillamine helps to decrease the amount of a certain substance (cystine) in the urine which can cause kidney stones.

Regulatory & Marketing

Labeler Name
Apothecon Pharmaceuticals Pvt Ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-07-2019
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 (76339-159). Click a package code to view its specific billing and regulatory data.

76339-159-01
1 BAG in 1 DRUM / 1 BAG in 1 BAG / 4.999 kg in 1 BAG
76339-159-02
1 BAG in 1 DRUM / 1 BAG in 1 BAG / 9.999 kg in 1 BAG

* 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 76339-159-00 identifies a specific commercial package of 1 bag in 1 drum / 1 bag in 1 bag / .999 kg in 1 bag of Penicillamine (UNFINISHED drug), a bulk ingredient labeled by Apothecon Pharmaceuticals Pvt Ltd. This powder is formulated for use and contains penicillamine 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 Apothecon Pharmaceuticals Pvt Ltd on September 07, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat rheumatoid arthritis, Wilson's disease (a condition in which high levels of copper in the body cause damage to the liver, brain, and other organs), and a certain disorder which causes kidney stones (cystinuria). For the treatment of rheumatoid arthritis, penicillamine is known as a disease-modifying antirheumatic drug (DMARD). It helps to decrease pain/tenderness/swelling in the joints. For the treatment of Wilson's disease, penicillamine binds to copper and helps it to be removed from the body. Decreasing copper levels helps to improve liver function and the mental/mood/nerve problems (such as confusion, difficulty speaking/walking) caused by the disease. For the treatment of cystinuria, penicillamine helps to decrease the amount of a certain substance (cystine) in the urine which can cause kidney stones.

How is this Apothecon Pharmaceuticals Pvt Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76339015900. 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)
76339-159-00
11-Digit CMS (5-4-2)
76339-0159-00

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