National Drug Code Number (NDC Number)

The National Drug Code Number is used to identify all drugs manufactured for human consumption in the United States. The Drug Listing Act of 1972 required that all manufacturers of drugs supply the Federal Food and Drug Administration (FDA) with a unique number for each and every medication. 

The national drug code is a three-segmented number, and it is expected that the Pharmacy Technician will be able to understand each segment what each segment means.

Segment 1 

 XXXX(X)

The first segment (Labeler Code) can be 4 or 5 digits in length, it is assigned by the FDA, and it represents the manufacturer of the drug.

Segment 2

XXX(X)

The second segment (Product Code) can be 3 or 4 digits in length, and it represents the product strength, dosage form, and formulation.

Segment 3

XX(X)

The third segment (Package Code) can be 2 or 3 digits in length, it represents the package form and size

The National Drug Code looks something like this:

                                                            XXXX(X) XXX(X) XX(X)

When you are studying for the National Pharmacy Technician Certification Exam (PTCE or ExCPT) you will need to fully understand and be able to identify each segment.

Federal Food, Drug, & Cosmetic Act of 1938

In 1938, the United States government became involved in drug regulation to make sure that drugs were both safe and effective. Even after the establishment of the Pure Food and Drug Act of 1906, thousands of patient drug-related deaths occurred each year.

The act was instituted after one particularly grisly incident where 100 patients in the United States died from a chemical additive used to dissolve the drug sulfanilamide.

The main objectives of the Federal Food, Drug, and Cosmetic Act of 1938 was to establish testing and safety standards and to ensure that drugs were neither adulterated nor misbranded.

• Adulterated Drug - Any drugs that contains decomposed substances.
• Misbranded Drug - Any drug whose label is false, misleading, or proper warnings and directions are excluded.

The act has twenty chapters and includes prohibited actions & penalties for food, drugs and devices, cosmetics, bottled water,  tobacco products, homeopathic preparations,dietary suppliments, imports/exports,and it establishes the general authority of the FDA.

In addition, the act allows the Federal Trade Commission (FTC) to oversee the marketing/advertising of all FDA regulated products.

The Federal Food, Drug, and Cosmetic Act of 1938 replaced the weaker Pure Food and Drug Act of 1906 and it strengthened and cemented the role of the FDA.

Pure Food and Drug Act of 1906

The Pure Food and Drug  Act of 1906  is the law that first established

the role of the Food and Drug Administration (FDA). This legislation was
passed by Congress to set standards for drug purity and strength.

Even though the Pure Food and Drug Act of 1906 is generally regarded
as the establishing law of the FDA, it would be 32 more years until the agency
first became the powerhouse they are today.