Penicillamine
NDC Package 43975-309-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Penicillamine 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). Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 43975-309 and is authorized under FDA application ANDA209921.

Identification & Billing

NDC Package Code
43975-309-10
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
11-Digit Billing Format
43975030910
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Penicillamine
Dosage Form
-
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
Ani Pharmaceuticals, Inc.
FDA Application #
ANDA209921
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-07-2019
End Marketing Date
06-30-2022
Listing Expiration
06-30-2022
Exclude Flag
D
Sample Package
No

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 43975-309-10 identifies a specific commercial package of 100 capsule in 1 bottle of Penicillamine, labeled by Ani Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Ani Pharmaceuticals, Inc. on May 07, 2019. The current certification is valid through June 30, 2022.

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 Ani Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43975030910. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
43975-309-10
11-Digit CMS (5-4-2)
43975-0309-10

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