When adding a new HTA External Code System Information page ensure that a row for the code system is added to the index at the following link: HTA — External Terminologies - Information – Code System Metadata Records Index
Data element name | Sub data element name | Value |
Code System Owner | Name | U.S. Food and Drug Administration (FDA) |
| Website | https://www.fda.gov | |
| Email address | fda-srs@fda.hhs.gov | |
| Phone number | 1-888-463-6332 | |
| Address | 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States | |
| Code System Maintainer (Steward) | Name | U.S. Food and Drug Administration (FDA) |
| Website | https://www.fda.gov | |
| Email address | fda-srs@fda.hhs.gov | |
| Phone number | 1-888-463-6332 | |
| Address | 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States | |
| Code System Publisher | Name | U.S. Food and Drug Administration (FDA) |
| Website | https://www.fda.gov | |
| Email address | fda-srs@fda.hhs.gov | |
| Phone number | 1-888-463-6332 | |
| Address | 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States | |
| Code System Names | Formal name of the code system | Unique Ingredient Identifier |
| Short name of the code system | UNII | |
| Code System Technical Identifiers | HTA-endorsed URI | http://fdasis.nlm.nih.gov |
| HTA-endorsed OID | 2.16.840.1.113883.4.9 | |
| Other URIs | ||
| Other OIDs | ||
| Case Sensitive Codes (TRUE/FALSE) | TRUE (default value) | |
| Code System Information | Link | https://www.fda.gov/industry/fda-data-standards-advisory-board/fdas-global-substance-registration-system |
| Notes | A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication. | |
| Arrangement or agreements with HL7 for use of content | ||
| Version management | ||
| Code System Copyright, Intellectual Property and Licensing | Copyright Statement | |
| Copyright Information | Unless otherwise noted, the contents of the FDA website (www.fda.gov) — both text and graphics — are not copyrighted. They are in the public domain and may be republished, reprinted and otherwise used freely by anyone without the need to obtain permission from FDA. Credit to the U.S. Food and Drug Administration as the source is appreciated but not required. | |
| Intellectual Property Information | ||
| Licensing Information | ||
| HTA endorsement status (Draft, In review, Endorsed for use, Pending re-endorsement, Retired) | Value | Draft |
| Assignment date | 20220811 | |
| HTA review status | Last review date | 20220811 |
| Next review date | 20230811 | |
| Information current as at (date) | 20220811 |