According to the Drug listing act of 1972, all registered drug establishments must provide the current list of all drugs manufactured, processed, prepared, propagated, compounded or processed for commercial distribution in their facility to FDA. These drugs products are identified and reported by using a unique three segment number called National Drug Code (NDC), which serves as universal product identifier for human drugs.
NDC number is a unique 10-digit, 3–segment numeric identifier assigned to each drug listed under Section 510 of FD&C act. Each NDC number identifies the labeler, product and the trade package size of the drug.
- The first segment of NDC is known as labeler code, which is a unique 5 digit number assigned by FDA to each establishment that manufactures (including contract manufacturers, re-packers or re-labelers) or distributes (under its own name- Private label distributor).
- Second segment, which is the product code, identifies the specifications (strength, dosage form and formulation) of a drug for a particular manufacturer. This denotes that different formulations or different strengths of the same formulation should be assigned different product codes.
- The third segment, the package code, classifies package sizes and types. The second and third segments of NDC should be assigned by the labeler. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.
NDC Labeler code request to FDA should be submitted in SPL (structured Product Labeling) format via FDA ESG (electronic submission gateway). Labeler is responsible for each NDC directory entry submitted through SPL files. Entry in NDC directory doesn’t indicate that FDA approved or verified the information of the drug. Assignment of NDC number to non-drug products is strictly prohibited. Under FD&C act, registration of a drug establishment or assignment of NDC number does not denote that FDA’s approval of the company or its products.
Even though NDC number is a mandatory requirement, but it is not required to appear on all drug labels and including the label of any prescription drug carton given to a consumer. However, if the same drug product that are sold or used in the hospitals are required to put bar code on their products.
NDC Directory does not include animal drugs, blood products, API (Active Pharmaceutical Ingredients), drugs manufactured exclusively for a PLD, or drugs that are marketed as a part of a kit or combination product or inner cover of a multi-level packaged product not marketed separately.
Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug Listing and US agent service to foreign facilities.
Sudha S
Regulatory Consultant
Mail: office@libertymanagement.us
Can i market a hand sanitizer (alcohol 65% ) as a cosmetic without fda approval ? if fda approval is required, how long it will take to get the approval ? and what is the cost involved ?
Antiseptic hand sanitizer with 65 percentage alcohol is in OTC Tentative monograph, so you don’t need an FDA Approval but you have to comply with FDA hand sanitizer OTC Monograph. FDA recently issued a final rule on anti septic hand sanitizer which put around 28 active ingredients in ineligible status.
since the active ingredient is in the monogrpah, there is no FDA fees, if you need assistance with FDA registration and listing, please visit our FDA registration fees page for our fee schedule.
Will a design change to an inhaler device with an existing formulation need a new NDC number? There is no change in the formulation.
Not a new NDC number but you need to change the last 2 digits of the NDC since you are changing the packaging medium. Also you need to update the label image of the product in dailymed.
Thank so much, Can you help me in updating my listing? What is your fee?
Sure we can help you with drug listing update. If you have the previous SPL files, our fees for listing update is $199/listing.
Hi, My company manufactures and distributes a prescription drug but outsources packaging to a third party. Whose NDC code will appear on the label of the product – my company or the packaging company?
Thanks in advance.
Both the manufacturer and the packaging companies needs to have FDA establishment registration. Since the packaging company is only packing the drugs they don’t need to list the drugs with FDA. But as manufacturer of the drugs, you need register the establishment and also needs to list the drugs with FDA with your own labeler code. So only your company NDC number should be on the label of the product.
My company has an NDC number that was obtained years ago. We can’t locate it. Can you help me find it or obtain a new one? We would like to list a drug manufactured in China. The manufacture is already registered and listed. Please quote me your price for both NDC and listing of 1 drug. What is the process?
How much time does it take? Thanks!
If you already have a labeler code assigned by FDA, you cannot apply for new one. We will assist you to get the labeler code from FDA.
Our fees for labeler code request is $649( if you already have one, we will waive this fees) and $399/drug for listing. Approximately it will take 3 weeks to complete the project.