Difference between revisions of "Drug Terminologies"
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The first segment is the labeler code, and the other two segments are the product code and package code. | The first segment is the labeler code, and the other two segments are the product code and package code. | ||
| − | + | FDA Labeler Code: This is a code that is assigned by the FDA to the manufacturer, packager or re-packager of the drug as part of the application process. | |
| − | + | Product Code: This is a code that is selected by the owner of the FDA Labeler Code. It represents the unique combination of the drug, the dosage form and strength that will be packaged by that owner. | |
while the code is assigned by the owner of the labeler code it must be registered with the FDA. | while the code is assigned by the owner of the labeler code it must be registered with the FDA. | ||
| − | + | Package Code: This is the Code that represents the package size or package grouping of the drug. | |
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| + | '''UNIQUE INGREDIENT IDENTIFIER(UNII)''':The United States Food and Drug Administration maintains a Substance Registration System (SRS)which identifies all substances present in drugs, biologics, devices or foods. The UNII is an identifier for a single defined substance. | ||
| + | The UNII is one of the core components of the United States Federal Medication Terminology. It is used in the FDA's Structured Product Labeling, used in the generation of the national Library of Medicine's (NLM's)RxNorm. | ||
Revision as of 23:20, 28 October 2014
DRUG TERMINOLOGIES
INTRODUCTION: There are federal and non-federal Drug terminologies/standards.
Federal terminologies include the Food and Drug Administration's National Drug Code (NDC), the Structure Product Labeling(SPL)and the Unique Ingredient Identifier (UNII), the National Library of Medicine RxNorm, the National Drug File Reference Terminology ( for specific drugs)and non federal Standard Organization like the National Council for Prescription Drug Program.
NATIONAL DRUG CODE It is Universal product Identifier for drugs intended for humans in the United States. The Drug Listing Act of 1972 mandates all drug establishments to provide the Food and Drug Administration with the list of all drugs that are prepared ,manufactures, compounded or processed for commercial distribution. The FAD publishes the NDC and information submitted in the NDC Directory which is updated daily. The national drug code is used in drugs dispensing record keeping, billing and reimbursement etc. The National Drug Code is present in medication package and inserts of prescription and nonprescription ( over-the counter)drugs. The National Drug Code is a unique 10-digit , three semi-fixed-length data fields: The first segment is the labeler code, and the other two segments are the product code and package code.
FDA Labeler Code: This is a code that is assigned by the FDA to the manufacturer, packager or re-packager of the drug as part of the application process.
Product Code: This is a code that is selected by the owner of the FDA Labeler Code. It represents the unique combination of the drug, the dosage form and strength that will be packaged by that owner. while the code is assigned by the owner of the labeler code it must be registered with the FDA.
Package Code: This is the Code that represents the package size or package grouping of the drug.
UNIQUE INGREDIENT IDENTIFIER(UNII):The United States Food and Drug Administration maintains a Substance Registration System (SRS)which identifies all substances present in drugs, biologics, devices or foods. The UNII is an identifier for a single defined substance.
The UNII is one of the core components of the United States Federal Medication Terminology. It is used in the FDA's Structured Product Labeling, used in the generation of the national Library of Medicine's (NLM's)RxNorm.
