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NDC Number

2

Nov

2016

What is NDC Number (National Drug Code) ?

NDC  number  is 10 digit number which is grouped in three sets. 

NDC number has three components  

  1. Labeler code 
  2.  Product code
  3. Pack code 

Labeler code identifies the labeler or responsible owner of the drug. Labeler can be any company who performs operations such as manufacturing, packing or distributor of the products. 

Second set of  NDC number is product specific, so labeler has to assign   three or four   digit product code  for each drug  they manufacture or distribute. Product code should be unique for each product. Drug products  with same active having different  strength or formulation will be  considered as different products.  

Last set of NDC number corresponds to pack code, which should identify the pack size and pack type.

So, NDC number format is 10 number digit can be a set of   4-4-2, 5-3-2, or 5-4-1.

Examples of NDC number format

If a company manufactures  Drug A having 25 mg  and 50 mg strengths in two pack sizes of 50’s and 100’s count, then NDC number will be as follows.

Consider 12345 , as a 5 digit number as labeler code  assigned by FDA to labeler.

NDC for Drug A 25 mg of 50 counts :- 12345-678-10

NDC  for Drug A 25 mg of 100 counts :- 12345-678-20                                                                           

NDC  for Drug A 50 mg of 50 counts :- 12345-876-10

NDC  for Drug A 50 mg of 100 counts  :-12345-876-10

NDC for  Drug A 50 mg of 10 counts blister :- 12345-876-30

In the above example;

12345 is FDA assigned labeler code

678 is the product code for Drug A 25 mg

876 is the product code for Drug A 50 mg

Since there is change in the active ingredient composition product is changed. 

10 is the pack code for 50  tablets in container

20 is the pack code for 100 tablets in container

30 is the pack code for 10 counts in blister

Alternatively, you can assign the 4  digit product code and 1 digit  pack code.  However, once you follow NDC numbering format the same format should be continued for all the future products.

FDAbasics  provides complete assistance for obtaining the labeler code,  assigning NDC number and drug listing, if you have any questions please write to us.

It will take about 10  working  days to obtain the labeler code from FDA. After obtaining the labeler code we can help companies to assign the NDC number and completed the drug listing process. 

Please contact us for more information.

 

 

 

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