NDC Registration | National Drug Code Labeler Registration | What is an NDC Number?

The compliance experts at Quality Smart Solutions can help you with NDC Labeler Code registration. Our experts will assist you in preparing and submitting a request in SPL (Structured Product Labeling)  via ESG or the FDA’s CDER Direct Portal for NDC registration and enable you to sell your drug products in the US market.

NDC (National Drug Code) numbers are unique, 10-digit identifiers assigned to each prescription drug in the United States.  This code helps identify drugs in a way that can be easily understood and recognized by medical professionals, pharmacies, and insurance providers.

What is an NDC Number NDC Registration

What is an NDC Number and how do i look up an NDC number?

NDC is an acronym for National Drug Code (NDC). It is a  unique, three-segment 10 digits number used to identify drug products. The first segment of the code assigned by FDA represents the establishment. The second and third segments are assigned by the labeler of the product. As a drug establishment, you need to provide the FDA with a current list of all drugs manufactured, packaged, prepared, compounded or processed for sale in the US at your facility. 

The Food and Drug Administration strives to publish the listed NDC numbers in the NDC Directory which is updated daily. To obtain an NDC Labeler code, the labeler is required to prepare and submit an “NDC Labeler Code Request” to the FDA. Please note that the FDA accepts the request only via ESG or the FDA’s CDER Direct Portal.

The National Drug Code (NDC) is a unique identifier for prescription and over-the-counter drugs. It was developed in 1967 and was originally intended to be used by physicians, pharmacists, and insurance companies as a way to track drug use in hospitals. Today, the NDC serves many purposes: it enables pharmacists to check medications against prescriptions and identify potentially dangerous drug interactions; it helps researchers study trends in health care; and it’s even how bar code scanners read product information on packages at the supermarket.

How are NDC Numbers Used to Identify Pharmaceutical Products?

NDC numbers are used to help accurately identify drug products, as well as to ensure that patients are taking the correct drug product and strength. NDC numbers can also be used to verify accuracy when submitting claims for prescription drugs. Doctors and pharmacists rely on accurate and complete NDC information to accurately fill prescriptions, which helps reduce possible medical errors. Additionally, the NDC number is important for tracking safety recalls and adverse events related to any particular product.

Where to find your products NDC number?

The National Drug Code (NDC) is a unique number used to identify drugs and other pharmaceutical products in the United States. NDC numbers consist of nine numeric digits, which are typically packaged together with packaging and labeling requirements. The first six digits identify the product, while the last three digits serve as a batch or lot number.  The NDC number can be found on your drug packaging, including:

  • A box containing only one bottle of pills or capsules with an NDC label affixed to it;

  • A bag containing more than one bottle of pills or capsules with an NDC label affixed to it;

  • An individual bottle that contains only one type of pill with an NDC label affixed to it;

  • Individual wrappers for blister packs with an NDC label affixed inside each wrapper;

How to find your NDC number and how to use it?

To find the NDC number of a drug, simply type in the active ingredient or product name into a database. You can use a database like DrugBank or RxNorm to search for your drug of choice.

Drug databases are required by law to have every single medication that exists in their respective countries or regions. If you can’t find an existing NDC number, then it means that this medicine does not exist yet and if you want to make it yourself (which is illegal), you will have to make up a new one yourself!

Contact the manufacturer:

The best way to find your NDC number is by contacting the manufacturer of your drug. Often, manufacturers will be able to help you locate the number for free. They may also be willing to give you the NDC code in exchange for a small fee or donation.

NDC Numbers as part of a barcode:

You can use your NDC number as part of a barcode, which is a machine-readable optical label typically found on drug packaging. The standard UPC barcode is 12 digits long and consists of two parts:

  • A 2-digit numeric code (e.g., 01) that tells what type of product it is (in this case, drugs)

  • A 10-digit numeric code that uniquely identifies the item within that product type (in this case, the drugs themselves).

What does an NDC Labeler Code Look Like?

Assume you have been assigned 54321 – 123 – 50 labeler code for 50 ml body lotion tube with active ingredient Glycerin 20% manufactured by ABC Company.

Labeller

54321

ABC Company

Drug

123

body lotion Glycerin 20%

Package

50

50ml Tube

An example of an NDC Labeler Code could be “54321 – 123 – 50” for a 50 ml body lotion tube with active ingredient Glycerin 20% manufactured by ABC Company.

How Does an NDC Number Help when Ordering Prescriptions?

An NDC number makes it easier for pharmacies to fill orders accurately and efficiently. When a prescriber enters the NDC number on an order, the pharmacy can quickly locate the medication and check that it’s safe to administer. This helps reduce the potential for errors in prescription orders, thereby keeping patients safe from medical mistakes. Knowing the correct NDC number is essential for proper medication ordering.

Why is it Important to Include an NDC Number in a Prescription Order?

In order for a pharmacy to accurately fill a prescription, the prescriber must include an NDC number on the order. The NDC number allows the pharmacist to quickly locate and check the medication in their records. This helps ensure that any prescriptions filled are accurate and safe for patient use, as it eliminates potential errors caused by incorrect drug orders or confusion between medications with similar names. Knowing the correct NDC number is important to ensure appropriate and safety-based medication ordering.

How are Product Identities Verified with an NDC Number?

The NDC number is the main identifier that verifies the product’s identity and provides further information about it. This includes features such as manufacturer, product type, strength, package size, etc. Without an accurate NDC number, the pharmacy may incorrectly fill a prescription with the wrong medication. Additionally, when requesting additional supplies of a medication from wholesalers or trade partners, the NDC number is used to track and verify product information quickly without manually searching through records to find what is needed.

What Are the Benefits of Using an NDC Number for Tracking and Management Purposes?

Using an NDC number provides a unique identifier when processing orders and requests. This helps to quickly and accurately track medication orders, reduce ordering confusion, ensure accuracy in refills and prevent fraud around controlled substances. In addition, NDC numbers are important for proper reimbursement for medication-related costs with insurance companies as well as tracking supply usage to aid in inventory management. By using the NDC number system, medical professionals can ensure that they’re providing accurate medication information to their patients. This code system helps reduce errors at the point of sale and helps provide clear product identifiers so pharmacists can quickly retrieve the right medication for the right person. Additionally, utilizing this coding system assists retailers in processing medical claims more quickly, saving valuable time and reducing costs associated with manual inputting of information.

Frequently Asked Questions

NDC is an acronym for National Drug Code (NDC). It is a unique, three-segment 10 digit number used to identify drugs. The first segment of the code assigned by FDA represents the establishment. The second and third segments are assigned by the labeler. As a drug establishment, you need to provide FDA with a current list of all drugs manufactured, propagated, prepared compounded or processed for sale in the US at your facility.

The US Food and Drug Administration (FDA) strives to publish the listed NDC numbers in the NDC Directory which is updated daily. To obtain the NDC Labeler code, the labeler is required to prepare and submit an “NDC Labeler Code Request SPL” to the FDA. Please note that the FDA accepts the request only via ESG or CDER Direct Portal.

Where can I find an NDC number for my drug?

The bar code, or Universal Product Code (UPC) symbol is the series of black vertical lines seen on any Point-of-Sale product. On the other hand, a National Drug Code (NDC) number is a unique three-segment 10-digit number, with part of the number assigned by the FDA. NDC numbers apply to drugs only, whereas UPC numbers would apply to any product that is made available to consumers.

The first 5 numbers are used to identify the drug manufacturer.  The 4 numbers in the middle are used to identify the drug itself.  Finally, the last 2 numbers are used to identify the packaging.

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