FDA Data Element Number. None.
CDER Data Element Number. C-DRG-00401
Data Element Name. Ingredient Name.
Description. This standard provides for all ingredients, both active and inactive. It may also be used for contaminants and similar chemicals not necessarily desirable in the end-product.
Source. CDER Ingredient Dictionary (CDID) is directly linked to DRLS, DDE, and OTC through the CD# to the standard ingredient term. It is indirectly linked to the COMIS system by identifying the ingredients associated with IND's and NDA's.
Relationship. Related terms are the Chemical Abstracts Service Number (CAS NUMBER), and the FDA source document (SOURCE) that the ingredient name was found in.
FDA Specifications. None.
CDER Specifications. Ingredient Name shall consist of an alphanumeric term which has a maximum length restricted to 240 characters. A detailed description of the process of arriving at an ingredient name is found under the data values section. Since the number of entries was so voluminous, it was felt that a description of the process would better serve those interested. Actual data values are not static, and can be determined by contacting DDIR at 301-443-3910.
Codes representing these Ingredient Names shall consist of nine characters (two alpha characters followed by 7 numeric characters). The alpha portion of the code shall be determined by the responsible chemist. The first 6 digits of the numeric portion of the code shall be generated sequentially by computer, with the seventh digit also determined by computer (based upon the last number in the sum of the product of each integer times its numeric location from the right).
Logical flags delineating whether an ingredient name is a preferred term (PT) or a synonym term (SY) are also part of the ingredient name.
FDA Approved Date. None.
CDER Approved Date. April 12, 1994.
FDA Revised Date.
CDER Revised Date.
Data Values. See CDID.
CDID Nomenclature Standards.
|1.||All ingredients entered into the CDID must be preferred terms. The CDER guidelines for determining preferred names for drugs appear in the CDER Staff Manual Guide.|
|2.||Established Names. Established names are classified according to Section 502 (c) (2) of the Act as follows:|
|a.||Official Name. Section 508 of the FD & C Act, as amended, authorizes the Secretary of Health and Human Services to designate an official name for any drug if it is determined that such an action is necessary or desirable in the interest of usefulness and simplicity.|
|b.||Official Compendium Name. If an official name has not been designated for the drug, and the drug is recognized in an official compendium (U.S. Pharmacopeia, National Formulary, or Homeopathic Pharmacopeia of the U.S.), then the Official title in the compendium is the established name.|
|c.||Common or Usual Name. If a drug has neither an official or compendium name, then the common name for the drug or ingredient is the established name.|
|3.||If a drug contains 2 or more ingredients, the established name must be given for each ingredient.|
|4.||Utility of Established Names. The established name facilitates communication by providing a common designation for identical drugs, or combinations of drugs, available from several sources. It may be used without restrictions imposed by a proprietary trademark.|
|a.||The FDA has the final authority to accept or reject any name proposed as an established name, including a USAN.|
|b.||In the official name, the word salt, ester, or other chemical combination in which the drug may exist is generally omitted and only the parent or stem name is given. However, the full name of the drug must be shown in the drug labeling.|
|c.||The official name is the only name of the drug to be used in an official compendium published after such a name has been designated as official.|
CDID Format Standards.
The following format standards were established for the CDID above and beyond those dictated by the agency. These were established by the ingredient dictionary subcommittee to have 1) standards that were in compliance with Agency policy, and 2) standards for ingredient nomenclature that were not covered by the agency or USAN.
|1.||Guidelines for making entries.|
|a.||The preferred order for the name of an inorganic salt and well known salts of simple organic acids is cation-anion.|
|b.||The preferred order for the name of an organic compound is the pharmacologically active portion first, and the salt second.|
|c.||The name of a substance should not indicate the state of hydration, the morphology, the mode of preparation, or the dosage form. These terms are only used when required to prevent ambiguity.|
|d.||Federal law requires that the established name(s) of the active ingredient(s) of the drug appear on the approved product label/labeling and this should conform to USAN standards. When this nomenclature differs, USAN standards should be entered into the Dictionary as the preferred term with the term on the label as the synonym.|
|2.||Name Selection Schema.|
|a.||When possible, selected names will follow USAN convention. The USAN Council chooses each U.S. Adopted Name with the expectation that it will be suitable for subsequent designation as the title of the monograph, should the article be recognized in the Official United States Pharmacopeia or National Formulary, and designation by the FDA as the established name for the article concerned.|
|b.||The following priority selection is followed when choosing a preferred name or a drug or ingredient:|
|a)||Official Name (FDA)|
|b)||Official Compendia Name|
|c)||USAN Name for articles not currently designated "official" or currently recognized in Official Compendia.|
|d)||Common or Usual Name|
|3.||Name Selection Format and Considerations.|
|a.||Elements such as dosage form and route of administration will not be included unless it reflects a standardized formulation that is used as an ingredient in a drug product and is recognized in a USP monograph as such (ex. Aluminum Hydroxide Gel).|
|b.||To facilitate data retrieval, a minimum of punctuation is utilized.|
CDID Rules for Non-USAN Names.
The following rules and standards are utilized if USAN does not have an established name, it is inadequate in its specificity, or is inconsistent in its convention.
|1.||All established generic ingredient will have a chemical name entered as a synonym. However, if a generic name has numerous salt derivatives, then the chemical name for only one of these salt derivatives will be entered.|
|2.||Chemical names for investigational drugs are entered as a preferred term only when there is no USAN adopted names available.|
|a.||Active Ingredients: Proprietary names are generally not entered as preferred terms for active ingredients except as a synonym to serve as a cross reference.|
|b.||Inactive Ingredients (excipients): Proprietary names are entered as preferred terms for excipients that represent formulations for flavors, colors, etc.|
|4.||Company Drug Code Names for investigational substances are entered as a preferred term only when there is no other reference available (e.g. chemical name).|