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

2020-04-24

Version

2020-04-24

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_NameAn 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.stringrequired : 1
RouteA route of administration is a way of administering a drug to a site in a patient.string-
Dosage_FormA dosage form is a form in which a drug is produced and dispensed.stringrequired : 1
CAS_NumberThe 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_IdentifierThe “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_AmountThe "potency amount" field specifies the maximum amount of inactive ingredient for each route/dosage form containing that ingredient.string-
Potency_UnitThe "potency unit" field specifies the unit type associated with the potency amount.string-
Is_Record_UpdatedTrue if the record is updated.boolean-

Data Preview

Ingredient NameRouteDosage FormCAS NumberUnique Ingredient IdentifierPotency AmountPotency UnitIs Record Updated
.ALPHA.-TERPINEOLTOPICALLOTION9855521334LVV8W11.0%w/w
.ALPHA.-TOCOPHEROLBUCCALFILM, SOLUBLE1406184H4N855PNZ10.07mg
.ALPHA.-TOCOPHEROLINTRAVENOUSINJECTION, POWDER, FOR SUSPENSION1406184H4N855PNZ10.64mg
.ALPHA.-TOCOPHEROLORALCAPSULE1406184H4N855PNZ15.0mg
.ALPHA.-TOCOPHEROLORALSOLUTION1406184H4N855PNZ11.05mg/1ml
.ALPHA.-TOCOPHEROLORALTABLET1406184H4N855PNZ142.5mg
.ALPHA.-TOCOPHEROLORALTABLET, CHEWABLE1406184H4N855PNZ10.1mg
.ALPHA.-TOCOPHEROLORALTABLET, EXTENDED RELEASE1406184H4N855PNZ11.34mg
.ALPHA.-TOCOPHEROLORALTABLET, FILM COATED1406184H4N855PNZ1
.ALPHA.-TOCOPHEROLTOPICALOINTMENT1406184H4N855PNZ1