FAQs
How do I find the correct code? Answer: NDC numbers are listed on drug packaging in 10-digit format, however, to be recognized by payers, they must be converted to an 11-digit 5-4-2 sequence.
How do you read the National Drug Code? ›
The first five digits indicate the manufacturer or the labeler; the next four digits indicate the ingredient, strength, dosage form and route of administration; and the last two digits indicate the packaging. The FDA assigns the manufacturer portion of the code; the manufacturer supplies the rest.
How do you get an 11-digit NDC number? ›
Converting NDCs from a 10-digit to an 11-digit format requires placing the zero in the correct location based on the 10-digit format.
- For a 10 digit NDC in the 4-4-2 format, add a 0 in the 1st position.
- For a 10 digit NDC in the 5-3-2 format, add a 0 in the 6th position.
The 3 segments of the NDC identify the labeler, the product, and the commercial package size. The first set of numbers in the NDC identifies the labeler (manufacturer, re-packager, or distributer).
What are the rules for NDC? ›
Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs requires a stregically placed zero, depending on the 10-digit format. The following table shows common 10-digit NDC formats indicated on packaging and the appropriate conversion to an 11-digit format.
What is the formula for NDC? ›
The formula for calculation is ndc = 1.41*(PV/GR&R)
PV = Part Variation – the real variation of the parts manufactured. GR&R = Gauge Variation – the variation of the measurement process.
What is an example of a National Drug Code? ›
Example NDC
For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. The first segment of numbers identifies the labeler. In this case, the labeler code "00777" is for Dista Products Company, the labeler of Prozac.
What is an invalid NDC code? ›
An invalid and or non-covered NDC code on the first line will cause the entire claim to deny. Invalid NDC codes: If the NDC code on each line does not follow the standard NDC format (i.e. typo) the entire claim will deny even if the first line contains a valid/covered NDC code.
Do I use the NDC on the box or the vial? ›
If the medication comes in a box with multiple vials, should I use the NDC number on the box or the NDC number on the individual vial? If the medication comes in a box with multiple vials, using the NDC on the box (outer packaging) is recommended.
What do the first five numbers represent in an NDC number? ›
The NDC number consists of 11 digits, broken into 3 sections in a 5-4-2 format. The first 5 digits identify the labeler code representing the manufacturer of the drug and are assigned by the Food and Drug Administration (FDA). The next 4 digits identify the specific drug product and are assigned by the manufacturer.
In some applications, the fully expanded 5+4 digit labeler+product code is used as a 9-digit number to identify a product regardless of packaging. Thus an 11-digit NDC can be transformed into a 9-digit NDC product code by removing the last two digits.
How do I generate an NDC code? ›
In order to get the NDC Labeler code, the labeler need to prepare and submit an "NDC Labeler code request SPL" to FDA. FDA will not accept the submission in paper format or via e-mail. The labeler need to submit the SPL via ESG or CDER Direct Portal.
How do you read NDC codes? ›
How is the NDC formatted? The 10-digit NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1, meaning that there are 4 or 5 digits for the labeler code, 4 or 3 digits for the product code and 2 or 1 digit(s) for the package code.
Who assigns national drug codes? ›
NDC Number
This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug.
Does the NDC number need to be on the label? ›
Sec. 201.2 Drugs and devices; National Drug Code numbers. The National Drug Code (NDC) number is requested but not required to appear on all drug labels and in all drug labeling, including the label of any prescription drug container furnished to a consumer.
What is the NDC format for claims? ›
The NDC number consists of 11 digits with hyphens separating the number into three segments in a 5-4-2 format (e.g., 12345-1234-12). The first five digits identify the manufacturer of the drug and are assigned by the U.S. Food and Drug Administration (FDA).
Is NDC the same as serial number? ›
The sNDC is composed of the National Drug Code (NDC) (as set forth in 21 CFR Part 207) that corresponds to the specific drug product (including the particular package configuration)4 combined with a unique serial number, generated by the manufacturer or repackager for each individual package.
