National Drug Codes (NDCs) can be a confusing topic, but with the right knowledge, you can understand their purpose and use them correctly. Our regulatory consultants will help you sort out the details about NDCs, including what they mean, how to interpret them, and the regulations that come with using them.
National Drug Codes (NDCs) are numbers issued by the FDA to identify specific drug products and packages. They are used to keep track of prescription and over-the-counter medications and can help doctors, pharmacists, manufacturers, payers, and other healthcare professionals determine what drug is being prescribed or dispensed. NDCs come in two basic formats — a 10-digit NDC or an 11-digit NDC.
NDCs are used to identify drug products in many different ways. For example, the 11-digit format is often used for billing purposes, while the 10-digit format can be used for ordering and reporting purposes. NDCs can also be used in electronic health records (EHR) systems to help track and compare medication use patterns. The NDC also serves as a key identifier when tracking pharmaceuticals across the supply chain. This helps ensure that medications are safe, effective, and properly labeled throughout their entire lifespan.
NDC numbers are made up of several components. An 11-digital NDC number is broken down into three separate parts; the labeler code (which identifies the manufacturer), a product code, and package size. The 10-digit format eliminates the package size and count part and only includes the labeler code and product code. The length of an NDC number can vary depending on whether it is for an individual or multiple items, so make sure to double-check the format you need before using an NDC on your product labels.
All drugs and biologics that are regulated by the FDA must include an NDC number on their label, including prescription drugs, over-the-counter medicines, and medical devices. However, not all products are required to have an NDC; dietary supplements and herbal remedies do not fall under this regulatory requirement. Additionally, some non-FDA-approved substances like homeopathic medicines may be exempt from needing an NDC code.
Incorrect NDC numbers can be problematic and have several implications. An incorrect code could be fraudulent, indicating that patients are receiving a counterfeit version of the product instead of the authentic version. Additionally, an inaccurate NDC may lead to insurance fraud if the product is billed against a code that doesn’t match the administered drug or biologic. Finally, incorrect use of NDCs could also create big issues with pharmaceutical data exchange centers, which are used to confirm eligibility for financial and other benefits programs.
OTC drugs sold in the United States must be labeled with a National Drug Code (NDC). This number on a product label shows that the medicine has satisfied all quality, safety, and efficacy standards. Any firm wanting to manufacture OTCs in the United States must guarantee that their product fulfills the criteria for safety and efficacy. They should check to see whether they are in compliance with GMPs and fulfills the labeling criteria outlined in 21 CFR part 201.66. In many circumstances, satisfying FDA standards can be a complicated task. Quality Smart Solutions can assist you in precisely and effectively preparing your OTC product registration and obtaining an NDC number for your product.
OTC Drug Monograph Application and the OTC New Drug Application (NDA) are the two processes through which every OTC Drug manufacturer or packager has to market drugs in the US market.
Whether you’re a domestic or foreign manufacturer or importer of OTC Drugs, you need to show evidence that you meet GMP requirements.
We'll prepare your application for establishment registration on behalf of your firm and submit it to FDA through the applicable ESG gateway.
At Quality Smart Solutions, we have the capability to offer assistance in all phases of the drug development and marketing process, including product development, facility registration, business planning, USA drug label compliance, and more.
Get solutions for NDC Labeler Code by preparing and making a submission request in Structured Product Labeling (SPL) format via FDA's ESG (Electronic Submission Gateway).
Our OTC Drugs specialists help register OTC drugs and submit important listing information on time for all drugs in commercial sales and distribution.
We’ll review pre-approval label or label development and guide you on labeling modification to ensure compliance with US Drug Label requirements.
We’ll prepare your application for establishment registration SPL on behalf of your firm and submit it to FDA through ESG gateway. We also help in the renewal process.
Partner with a certified US Agent for non-US firms. We’ll respond to FDA questions, help during meetings with officials, receive all essential documents, and provide them to you.
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