Others titles
- FDA Inactive Ingredients
- UNII Database
- Unique Ingredient Identifier Database
Keywords
- Inactive Ingredients
- UNII
- FDA Registration
- FDA Regulations
- Inactive Ingredients
- FDA Approval Calendar
- FDA Inactive Ingredients
- Unique Ingredient Identifier
Drugs Inactive Ingredients Database
The Inactive Ingredient Database provides information on inactive ingredients present in Food and Drug Administration (FDA) approved drug products. This information can be used by industry as an aid in developing drug products.
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Description
The Inactive Ingredient Database provides information on inactive ingredients present in Food and Drug Administration (FDA) approved drug products. For new drug development purposes, once an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered new and may require a less extensive review the next time it is included in a new drug product. For example, if a particular inactive ingredient has been approved in a certain dosage form at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar type of product.
About this Dataset
Data Info
Date Created | 2009-03 |
---|---|
Last Modified | 2022-04-21 |
Version | 2022-04-21 |
Update Frequency |
Quarterly |
Temporal Coverage |
N/A |
Spatial Coverage |
United States |
Source | John Snow Labs; US Food and Drug Administration (FDA); |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | Inactive Ingredients, UNII, FDA Registration, FDA Regulations, Inactive Ingredients, FDA Approval Calendar, FDA Inactive Ingredients, Unique Ingredient Identifier |
Other Titles | FDA Inactive Ingredients, UNII Database, Unique Ingredient Identifier Database |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Ingredient_Name | An inactive ingredient is any component of a drug product other than the active ingredient. Only inactive ingredients in the final dosage forms of drug products are included in this database. | string | required : 1 |
Route | A route of administration is a way of administering a drug to a site in a patient. | string | - |
Dosage_Form | A dosage form is a form in which a drug is produced and dispensed. | string | required : 1 |
CAS_Number | The acronym "CAS" stands for "Chemical Abstracts Service," a division of the American Chemical Society that provides comprehensive electronic chemical information services. CAS assigns unique CAS Registry Numbers to chemical substances. Many inactive ingredients have CAS Registry Numbers, which are useful in searching other databases for chemical information. The CAS Registry Number itself has no chemical significance. | string | - |
Unique_Ingredient_Identifier | The “Unique Ingredient Identifier” is a part of the joint USP/FDA Substance Registration System (SRS), which has been designed to support health information technology initiatives by providing unique identifiers for substances in drugs, biologics, foods, and devices based on molecular structure and/or descriptive information. | string | - |
Potency_Amount | The "potency amount" field specifies the maximum amount of inactive ingredient for each route/dosage form containing that ingredient. | number | level : Ratio |
Potency_Unit | The "potency unit" field specifies the unit type associated with the potency amount. | string | - |
Maximum_Daily_Exposure | integer | level : Nominal | |
Maximum_Daily_Exposure_Unit | The Maximum daily exposure (MDE) unit specifies the unit type associated with the maximum daily exposure. | string | - |
Is_Record_Updated | True if the record is updated. | boolean | - |
Data Preview
Ingredient Name | Route | Dosage Form | CAS Number | Unique Ingredient Identifier | Potency Amount | Potency Unit | Maximum Daily Exposure | Maximum Daily Exposure Unit | Is Record Updated |
.ALPHA.-TERPINEOL | TOPICAL | LOTION | 98555 | 21334LVV8W | 11.0 | %w/w | |||
.ALPHA.-TOCOPHEROL | BUCCAL | FILM, SOLUBLE | 1406184 | H4N855PNZ1 | 0.07 | mg | True | ||
.ALPHA.-TOCOPHEROL | INTRAVENOUS | INJECTION, POWDER, FOR SUSPENSION | 1406184 | H4N855PNZ1 | 0.64 | mg | |||
.ALPHA.-TOCOPHEROL | ORAL | CAPSULE | 1406184 | H4N855PNZ1 | 5.0 | mg | |||
.ALPHA.-TOCOPHEROL | ORAL | SOLUTION | 1406184 | H4N855PNZ1 | 1.05 | mg/1ml | |||
.ALPHA.-TOCOPHEROL | ORAL | TABLET | 1406184 | H4N855PNZ1 | 1.0 | mg | |||
.ALPHA.-TOCOPHEROL | ORAL | TABLET, CHEWABLE | 1406184 | H4N855PNZ1 | 0.1 | mg | |||
.ALPHA.-TOCOPHEROL | ORAL | TABLET, EXTENDED RELEASE | 1406184 | H4N855PNZ1 | 4.0 | mg | |||
.ALPHA.-TOCOPHEROL | ORAL | TABLET, FILM COATED | 1406184 | H4N855PNZ1 | 246.0 | mg | |||
.ALPHA.-TOCOPHEROL | TOPICAL | OINTMENT | 1406184 | H4N855PNZ1 |