NDC 0037-4401 Depen
Penicillamine Tablet Oral

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0037-4401?
    5. Depen Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Pharmacologic Classes
    10. Patient Education

Product Information

NDC Product Code0037-4401
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Depen
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Penicillamine
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Penicillamine
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Meda Pharmaceuticals
Labeler Code0037
SPL SET ID:38f8ae60-b354-11de-8a39-0800200c9a66
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		NDA019854
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		11-30-1978
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

Product Characteristics

Color(s)WHITE (C48325)
ShapeOVAL (C48345)
Size(s)14 MM
Imprint(s)37;4401
Score2

Product Packages

NDC Code 0037-4401-01

Package Description: 100 TABLET in 1 BOTTLE

Product Details

What is NDC 0037-4401?

The NDC code 0037-4401 is assigned by the FDA to the product Depen which is a human prescription drug product labeled by Meda Pharmaceuticals. The generic name of Depen is penicillamine. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 0037-4401-01 100 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Depen?

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.

What are Depen Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • PENICILLAMINE 250 mg/1 - 3-Mercapto-D-valine. The most characteristic degradation product of the penicillin antibiotics. It is used as an antirheumatic and as a chelating agent in Wilson's disease.

Which are Depen UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Depen?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes for Depen?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Penicillamine


Penicillamine is used to treat Wilson's disease (an inherited condition that causes copper to build up in the body and may result in serious symptoms) and cystinuria (an inherited condition which can lead to kidney stones). It is also used in combination with other treatments to treat severe rheumatoid arthritis (a condition in which the body's immune system attacks its own joints, causing pain, swelling, and loss of function) that did not get better after treatment with other medications. Penicillamine is in a class of medications called heavy metal antagonists. It works to treat Wilson's disease by binding to the extra copper in the body and causing it to leave the body through the urine. It works to treat cystinuria by binding to the substance that makes kidney stones and preventing it from building up and forming stones. It works to treat rheumatoid arthritis by decreasing some actions of the immune system.
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Product Label

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