National Drug Code

The National Drug Code (NDC) is a unique identifier assigned to every drug sold within the United States. Established by the Food and Drug Administration (FDA), the NDC serves to differentiate and catalog drugs based on their name, dosage, strength, manufacturer, and packaging.

Sandoz.Methylprednisolone.4mg

Background and Overview

The NDC is a crucial component of the healthcare infrastructure in the United States, facilitating drug identification, tracking, reporting, and billing. Each NDC is a unique 10-digit, three-segment number, representing the manufacturer (labeler), the product, and the commercial package size. This distinction is vital for ensuring the safety, effectiveness, and traceability of drugs within the medical and pharmaceutical sectors.

Format and Structure

The NDC's three-segment format is as follows:

• * Labeler Code: Assigned by the FDA upon request by the drug manufacturer or distributor, this segment identifies the company responsible for the product's marketing.
• * Product Code: This segment identifies the specific strength, dosage form, and formulation of the drug for a particular firm.
• * Package Code: Denoting the package size and type, this segment differentiates between various packaging configurations of the same drug product by a labeler.
• For instance, the medication Phentermine 15mg might have an NDC code like 12345-6789-01, whereas Phentermine 30mg may possess a different NDC, such as 12345-6789-02, reflecting the difference in dosage strength.

Importance of the NDC

• Safety and Traceability: The NDC allows for efficient tracking and recall of drugs in the event of contamination, adverse reactions, or other safety concerns.
• Billing and Reimbursement: Healthcare providers and pharmacies use the NDC to process and validate insurance claims, ensuring accurate reimbursement for services rendered.
• Research and Reporting: Epidemiologists and public health officials utilize the NDC to track drug usage trends, monitor public health, and inform policy decisions.
• Regulation and Oversight: The FDA uses the NDC to oversee the manufacturing, distribution, and post-market surveillance of drugs.

NDC Database

The FDA maintains an active NDC Directory, listing all currently marketed human drug products. This searchable database allows healthcare professionals, researchers, and the general public to retrieve information on any drug product by its NDC, proprietary name, active ingredient(s), labeler name, and other criteria. It's vital for professionals to be aware that not all drugs in the directory are approved by the FDA, as some may have been marketed prior to the drug approval regulations or fall under specific exemptions.

Updates and Changes to the NDC

Given the dynamic nature of the pharmaceutical industry, with continuous introductions, changes, or discontinuations of products, the NDC list is ever-evolving. When changes to a drug product occur that could affect its NDC status or classification, the labeler is responsible for notifying the FDA. Such changes could include variations in the formulation, packaging, or discontinuation of the product.

NDC code

Resources - National Drug Code

• US FDA's NDC code lookup
• Drug Code website

NDC codes: 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10

• Medical classification

Comprehensive list of medications or pharmaceutical drugs used in the United States with their NDC or national drug code, brand name, dosage, forms of administration etc. sorted alphabetically.

• Top 200 drugs
• Medicare drugs
• Canadian drugs
• Dictionary of drugs
• Encyclopedia of drugs
• List of FDA approved drugs
• List of drugs A-Z - sorted in multipage format
• Drug categories
• Drug dosage forms
• Habit forming drugs

External links

The following is the collection of detailed information and links to the National Institute of Health (NIH) comprehensive drug information portal and other reliable sources of information. Select the drug name below to show drug description, drug classification, other common drug names, and information on the reasons why prescribed, how medication should be used, and what possible side effects could occur.

Drug names

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Search for other drug names not listed above