Everything to know about Drug Registration & NDC drug number

Everything to know about Drug Registration & NDC drug number

drug registration, NDC number

The pharmaceutical industry ensures public health by developing, manufacturing, and distributing safe and effective medications. For any drug to be legally marketed in the United States, it must undergo a rigorous drug registration process and receive a National Drug Code (NDC) number. This article will delve into the essential aspects of drug registration and the significance of the NDC drug number in healthcare.

Understanding Drug Registration

Drug registration is a crucial step in the pharmaceutical industry that involves obtaining regulatory approval from government agencies to market a drug product. This process ensures that all medications meet strict safety and efficacy standards before making them available. Here’s a breakdown of critical components and steps involved in drug registration:

1. Preclinical Development: Before a drug can even be considered for registration, extensive preclinical research is conducted. This requires laboratory testing and animal studies to assess the drug’s safety, toxicity, and potential effectiveness.

2. Investigational New Drug (IND) Application: If the preclinical data is promising, the manufacturer submits an IND application to the U.S. Food and Drug Administration (FDA) or the relevant regulatory agency in other countries. The IND application includes information about the drug’s composition, manufacturing process, proposed clinical trials, and preclinical data.

3. Clinical Trials: Clinical trials are conducted in multiple phases to evaluate the drug’s safety and efficacy in humans. Phase I focuses on security and dosage, and Phase II involves larger groups to assess effectiveness and side effects. Phase III confirms effectiveness and monitors side effects in a larger population.

4. New Drug Application (NDA) or Biologics License Application (BLA): The drug manufacturer submits an NDA or BLA to the FDA after successful clinical trials. This application contains comprehensive data on the drug’s safety, efficacy, manufacturing processes, labeling, and proposed use.

5. FDA Review: The FDA reviews the NDA or BLA to determine whether the drug should be approved for marketing. This review process includes evaluating data from clinical trials, chemistry, manufacturing, labeling, and inspections of manufacturing facilities.

6. Approval: If the FDA approves the drug, it can be marketed and sold in the United States. The approval process may include labeling requirements, warnings, and restrictions.

7. Post-Marketing Surveillance: After approval, the drug continues to be monitored for safety and efficacy through post-marketing surveillance. Adverse events are reported and investigated, and the drug’s label may be updated.

The Role of the National Drug Code (NDC)

The National Drug Code (NDC) is a unique identifier assigned to each medication product in the United States. It plays a pivotal role in drug registration, distribution, and billing. The NDC number consists of three segments: the labeler code, product code, and package code, each separated by hyphens. Let’s break down the significance of each segment:

1. Labeler Code: The first segment, also known as the manufacturer code, is assigned by the FDA to the drug manufacturer, repackager, or distributor. It identifies the entity responsible for bringing the drug to market.

2. Product Code: The product code segment identifies the specific drug, strength, and dosage form. It differentiates between various drug formulations made by the same manufacturer.

3. Package Code: The package code segment indicates the packaging size and type, such as bottle, box, or vial. It helps differentiate between different package configurations of the same drug product.

The NDC number serves several critical purposes:

A. Drug Identification: The NDC number uniquely identifies and tracks drugs in the marketplace, facilitating accurate record-keeping and drug recalls when necessary.

B. Billing and Reimbursement: Healthcare providers use the NDC number when submitting claims to insurance companies and government programs like Medicare and Medicaid. It ensures that medications are accurately billed and reimbursed.

C. Drug Listing and Registration: Manufacturers and distributors use the NDC number to list their drug products with the FDA and meet regulatory requirements. This is an essential step in the drug registration process.

D. Drug Labeling: The NDC number is typically printed on a drug’s packaging and label. It provides essential information for healthcare professionals, pharmacists, and patients, helping them verify the correct medication.

The NDC Drug Number Format

The NDC number is structured in a 10-digit format, divided into three segments. Here’s a breakdown of the format:

  • The first segment contains 4 or 5 digits, representing the labeler code.
  • The second segment includes 3 or 4 numbers indicating the product code.
  • The third segment has two digits, meaning the package code.

For example, let’s consider the NDC number for a hypothetical medication:

  • Labeler Code: 12345
  • Product Code: 6789
  • Package Code: 01

The NDC number would be written as 12345-6789-01

This format allows for many unique combinations, accommodating various medications available.

The Role of the Labeler Code

The labeler code, the first segment of the NDC number, is assigned by the FDA to drug manufacturers, repackagers, or distributors. This code is a critical identifier; each entity involved in drug production or distribution must have a unique labeler code. Here’s how it functions:

1. Manufacturer Identification: The labeler code identifies the entity responsible for manufacturing or distributing the drug. This ensures transparency and accountability in the pharmaceutical supply chain.

2. Drug Listing: Manufacturers, re-packagers, and distributors use their assigned labeler code when listing their drug products with the FDA. This step is essential for regulatory compliance.

3. Billing and Reimbursement: The labeler code is used in the billing and reimbursement. When healthcare providers submit medication claims, the labeler code helps ensure that the correct entity is billed.

4. Tracking and Traceability: The labeler code is crucial in tracking and tracing drugs throughout the supply chain. It helps identify the source of medication and facilitates recalls when necessary.

The Role of the Product Code

The product code, the second segment of the NDC number, is a numeric identifier that specifies the specific drug product, its strength, and its dosage form. The labeler assigns this code and serves the following purposes:

1. Product Differentiation: Manufacturers use the product code to differentiate between various formulations of the same drug. For example, different medication strengths or separate dosage forms (tablets, capsules, liquid, etc.) will have unique product codes.

2. Accurate Identification: Healthcare professionals, pharmacists, and patients rely on the product code to accurately identify and prescribe the correct medication. It ensures that the right drug product is dispensed.

3. Regulatory Compliance: The product code is essential for regulatory compliance. When manufacturers list their drug products with the FDA, they include the product code to provide detailed information about the specific medications they offer.

4. Drug Labeling: The product code is typically printed on the drug’s packaging and label. It assists with accurately identifying the drug, its strength, and its dosage form.

The Role of the Package Code

The package code, the third and final segment of the NDC number, is a two-digit identifier that specifies a drug product’s packaging configuration and size. This code is crucial for several reasons:

1. Package Differentiation: The package code allows manufacturers to differentiate between various package sizes and types for the same drug product. For example, a medication may be available in different quantities, such as 30 tablets, 60 tablets, or 100 tablets, and each package size will have a unique package code.

2. Inventory Management: Pharmaceutical manufacturers, distributors, and pharmacies use the package code to manage inventory effectively. It helps them keep track of the quantity of each package size in stock and reorder as needed.

3. Dispensing Accuracy: Pharmacists and healthcare providers rely on the package code to ensure they dispense the correct quantity of medication to patients. This helps prevent errors and ensures that patients receive the prescribed dosage.

4. Regulatory Compliance: When listing a drug product with the FDA, manufacturers include the package code as part of the NDC number. This step is essential for regulatory compliance and provides detailed information about the various packaging options available for the medication.

5. Prescription Labeling: The package code is often included on prescription labels to help patients and healthcare professionals verify that they receive the correct medication quantity. It adds an extra layer of accuracy to the prescription and dispensing process.

6. Reordering and Procurement: Hospitals, pharmacies, and healthcare facilities use the package code when reordering medications from wholesalers or manufacturers. It ensures that the correct package size is ordered to meet patient needs.

7. Supply Chain Efficiency: The package code is crucial in maintaining efficiency in the pharmaceutical supply chain. It helps with tracking and traceability, allowing for the rapid identification of specific package sizes during distribution and delivery.

8. Patient Education: The package code can also serve as a reference for patient education. It helps patients understand the quantity of medication they should take and facilitates communication with healthcare providers about prescription refills and dosing instructions.

In summary, the package code is a vital component of the NDC number, providing essential information about the packaging configuration of a drug product. It serves multiple purposes, from accurate dispensing to inventory management and regulatory compliance. Healthcare professionals, pharmaceutical manufacturers, and regulatory authorities rely on the NDC number, with its package code segment, to ensure the safe and efficient distribution of medications to patients across the United States.

Is there anything else I should know as a drug manufacturer?

Yes, there are several additional essential considerations and aspects that drug manufacturers should be aware of regarding drug registration and the National Drug Code (NDC) system:

  1. NDC Variations: While the standard NDC format consists of 10 digits (in a 5-4-2 layout), there are variations, such as the 11-digit format (5-4-2 with a check digit) and the 5-3-2 format for over-the-counter (OTC) drugs. Manufacturers must be aware of the specific form applicable to their products.
  2. Unique NDCs for Different Dosage Forms: If a manufacturer produces the same drug in multiple dosage forms (e.g., tablets, capsules, and liquid), each dosage form typically requires a unique NDC. This allows for precise identification of each form.
  3. NDC for Private Labeling: Manufacturers who produce drugs for private labels (generic or store-brand medications) must assign NDCs to these products. Private-label NDCs should be distinguishable from the NDCs of the original manufacturer.
  4. Repackaging and Relabeling: Manufacturers involved in repackaging or relabeling activities, where drugs are removed from their original packaging and placed into new containers, must assign new NDCs for the repackaged products. These NDCs should reflect the new packaging configuration.
  5. NDC Updates: Manufacturers should keep their NDC information updated with the FDA. Any labeler, product, or package code changes, including discontinuations or updates, should be reported to the FDA.
  6. International Considerations: For manufacturers exporting drugs to global markets, it’s essential to understand that the NDC system is specific to the United States. Other countries may have unique product identification systems, and compliance with international regulatory requirements is crucial.
  7. FDA Registration and Listings: Drug manufacturers must register their facilities with the FDA and list their drug products and corresponding NDCs with the FDA’s National Drug Code Directory. This information should be kept accurate and updated regularly.
  8. Supply Chain Traceability: The NDC system facilitates traceability throughout the pharmaceutical supply chain. Manufacturers, distributors, and pharmacies rely on NDCs to track products, verify authenticity, and ensure accurate dispensing.
  9. Regulatory Compliance: Compliance with NDC requirements is a legal obligation. Manufacturers must adhere to FDA regulations governing drug registration, labeling, and reporting. Failure to comply can result in regulatory actions and legal consequences.
  10. Patient Safety: Accurate NDC labeling and tracking contribute to patient safety. Ensuring patients receive the correct medication, dosage form, and packaging configuration is critical in preventing medication errors.
  11. Serialization and Track-and-Trace: Besides NDCs, some jurisdictions and regulatory initiatives require drug serialization and track-and-trace systems for enhanced product security and supply chain transparency. Manufacturers should stay informed about relevant serialization requirements.
  12. Regulatory Changes: Regulations related to drug registration, labeling, and NDCs can change over time. Manufacturers should stay informed about updates and revisions to FDA requirements and adapt their processes accordingly.
  13. Consultation with Regulatory Experts: Given the complexity of drug registration and compliance with NDC requirements, manufacturers may benefit from consulting with regulatory experts or professionals experienced in pharmaceutical regulatory affairs to ensure full compliance and avoid potential pitfalls.

In summary, drug manufacturers must navigate the intricate drug registration process and the NDC system to bring safe and effective medications to the market. Staying informed about regulatory requirements, adhering to NDC standards, and maintaining accurate records are essential for regulatory compliance and ensuring the well-being of patients.

Are you looking to have your drug product registered with Health Canada? Quality Smart Solutions has a team of experts who are skilled with DIN applications. If you need help with your Drug Establishment License (DEL) Registration we can help with that as well. 

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About the author

Andrew Parshad
Andrew Parshad
Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices.


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