NDC (National Drug Code) is 10 digit number which is grouped in three sets. First set of five or six digits corresponds to labelar code, which FDA assigns to the labelar, such labelar code identifies the labelar or responsible owner of the drug. Labelar 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 labelar 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 set of 4-4-2, 5-3-2, or 5-4-1.
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 labelar code assigned by FDA to labelar.
NDC number for Drug A 25 mg of 50 counts :- 12345-678-10
NDC number for Drug A 25 mg of 100 counts :- 12345-678-20
NDC number for Drug A 50 mg of 50 counts :- 12345-876-10
NDC number for Drug A 50 mg of 100 counts :-12345-876-10
NDC number Drug A 50 mg of 10 counts blister :- 12345-876-30
In the above example;
12345 is FDA assigned labelar code
678 is the product code for Drug A 25 mg
876 is the product code for Drug A 50 mg
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
Tobias provides complete assistance for obtaining the labelar code, assigning NDC number and drug listing, if you have any questions please write to us.BACK