National Drug Code System
Encyclopedia
The National Drug Code System is a system that is designed to provide drug
s in the United States
with a specific 11-digit number that describes the product. Originally created under Medicare
to help identify drugs for reimbursement, the usefulness of the system has now become more widespread.
agents, insulin formulations, and prescription drug products, and herbal drugs distributed in the United States. Originally, the system was established by Medicare
as part of an outpatient drug reimbursement program and a method to identify drugs during commercial distribution. It now enjoys a more widespread application; however products may not be included in the directory if the firm has not communicated the most recent status to the Food and Drug Administration
(FDA) (e.g., drug has been discontinued). Data in the NDC are updated quarterly (March, June, September, and December). The FDA requires firms to submit updated registered drug lists in June or December of each year (or sooner as new information about a drug becomes available to the firm).
Drugs listed under the NDC
are identified by an 11-digit number divided into three segments. The first segment, assigned by the FDA, identifies the vendor (or labeler) involved with the manufacturing, packaging, or distribution of the drug. Product codes, listed in the second segment, comprise the generic entity, strength, and dosage form. The third segment, or package code, indicates the package size. The manufacturer assigns the second and third segments of the code for a given product. Notably, government agencies such as Medicaid
or Medicare, display the code in an eleven digit format with leading zeros.
The NDC system may assist in ensuring the safe dispensing of prescription medications. For example, outpatient pharmacists may use the NDC system to avoid confusion with look-alike/sound-alike drugs. See ISMP Quarterly Action Agenda: October-December, 2001 for an example. Also in an attempt to reduce or prevent medication errors, the FDA issued a final rule in February 2004 requiring bar codes for prescription drugs and blood products by February 2007. Minimum standards for the bar code include the NDC number.
The Directory is organized as follows:
At National Drug Code Directory, a search may be conducted by proprietary name, active ingredients, application number, NDC number, or firm name. The Orange Book and Micromedix's Redbook
also use NDC numbers in their information tyiuo assist in cross-referencing and identification.
For information specific to vaccines, see Vaccine Identification Standards Initiative.
For NDC and HCPCS crosswalk, see dmepdac.com.
Inclusion of a drug in the directory does not mean that the FDA has approved the drug or that Medicare
, Medicaid
or other payers will reimburse for it. It should also be noted the numbers may be reused. Some have attempted to move to a clinically-based code system to avoid some of the pitfalls of frequent changes and number reuse. http://www.amia.org/pubs/symposia/D200590.PDF
Drug
A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...
s in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
with a specific 11-digit number that describes the product. Originally created under Medicare
Medicare (United States)
Medicare is a social insurance program administered by the United States government, providing health insurance coverage to people who are aged 65 and over; to those who are under 65 and are permanently physically disabled or who have a congenital physical disability; or to those who meet other...
to help identify drugs for reimbursement, the usefulness of the system has now become more widespread.
Description
The NDC System provides a directory of selected over-the-counterOver-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
agents, insulin formulations, and prescription drug products, and herbal drugs distributed in the United States. Originally, the system was established by Medicare
Medicare (United States)
Medicare is a social insurance program administered by the United States government, providing health insurance coverage to people who are aged 65 and over; to those who are under 65 and are permanently physically disabled or who have a congenital physical disability; or to those who meet other...
as part of an outpatient drug reimbursement program and a method to identify drugs during commercial distribution. It now enjoys a more widespread application; however products may not be included in the directory if the firm has not communicated the most recent status to the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) (e.g., drug has been discontinued). Data in the NDC are updated quarterly (March, June, September, and December). The FDA requires firms to submit updated registered drug lists in June or December of each year (or sooner as new information about a drug becomes available to the firm).
Drugs listed under the NDC
NDC
NDC or ndc may refer to:*IATA code for Nanded Airport, India* ndc, "name daemon control program" in some Unix-based BIND name-server environments* N.D.C., a 2002 single by Australian band Jebediah* National Defence Commission of North Korea...
are identified by an 11-digit number divided into three segments. The first segment, assigned by the FDA, identifies the vendor (or labeler) involved with the manufacturing, packaging, or distribution of the drug. Product codes, listed in the second segment, comprise the generic entity, strength, and dosage form. The third segment, or package code, indicates the package size. The manufacturer assigns the second and third segments of the code for a given product. Notably, government agencies such as Medicaid
Medicaid
Medicaid is the United States health program for certain people and families with low incomes and resources. It is a means-tested program that is jointly funded by the state and federal governments, and is managed by the states. People served by Medicaid are U.S. citizens or legal permanent...
or Medicare, display the code in an eleven digit format with leading zeros.
The NDC system may assist in ensuring the safe dispensing of prescription medications. For example, outpatient pharmacists may use the NDC system to avoid confusion with look-alike/sound-alike drugs. See ISMP Quarterly Action Agenda: October-December, 2001 for an example. Also in an attempt to reduce or prevent medication errors, the FDA issued a final rule in February 2004 requiring bar codes for prescription drugs and blood products by February 2007. Minimum standards for the bar code include the NDC number.
The Directory is organized as follows:
- Product Trade Name or Catalog Name
- National Drug CodeNational Drug CodeThe National Drug Code is a unique product identifier used in the United States for drugs intended for human use. The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration with a current list of all drugs manufactured, prepared, propagated,...
(unique 11 digit, 3 segment number). The segments represent the labeler code, the product code and the package code. - Dosage Form
- Routes of Administration
- Active Ingredients
- Strength
- Unit
- Package Size and Type
- Major Drug Class
- FDA approved application number (note that “other” in this field means it may not have been approved).
At National Drug Code Directory, a search may be conducted by proprietary name, active ingredients, application number, NDC number, or firm name. The Orange Book and Micromedix's Redbook
also use NDC numbers in their information tyiuo assist in cross-referencing and identification.
For information specific to vaccines, see Vaccine Identification Standards Initiative.
For NDC and HCPCS crosswalk, see dmepdac.com.
Inclusion of a drug in the directory does not mean that the FDA has approved the drug or that Medicare
Medicare (United States)
Medicare is a social insurance program administered by the United States government, providing health insurance coverage to people who are aged 65 and over; to those who are under 65 and are permanently physically disabled or who have a congenital physical disability; or to those who meet other...
, Medicaid
Medicaid
Medicaid is the United States health program for certain people and families with low incomes and resources. It is a means-tested program that is jointly funded by the state and federal governments, and is managed by the states. People served by Medicaid are U.S. citizens or legal permanent...
or other payers will reimburse for it. It should also be noted the numbers may be reused. Some have attempted to move to a clinically-based code system to avoid some of the pitfalls of frequent changes and number reuse. http://www.amia.org/pubs/symposia/D200590.PDF