Others titles
- Unfinished Drugs National Drug Code Directory
- National Drug Code Products of Unfinished Drugs
Keywords
- NDC Database
- NDC Lookup
- NDC Number
- FDA Product Code
- Unfinished NDC
NDC Products of Unfinished Drugs
The National Drug Code (NDC) Products of Unfinished Drugs dataset contains NDC product listing data submitted for all unfinished drugs.
Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.
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Description
The dataset includes products data submitted for all unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Current regulations require a registered establishment to update its drug listing data in June and December of each year, or, at the discretion of the establishment, when a change occurs; therefore, FDA may not yet have been notified of recent changes before updating the NDC Directory.
About this Dataset
Data Info
Date Created | 2012 |
---|---|
Last Modified | 2022-07-22 |
Version | 2022-07-22 |
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 | NDC Database, NDC Lookup, NDC Number, FDA Product Code, Unfinished NDC |
Other Titles | Unfinished Drugs National Drug Code Directory, National Drug Code Products of Unfinished Drugs |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Product_ID | ProductID is a concatenation of the NDCproduct code and SPL documentID. It is included to help prevent duplicate rows from appearing when joining the product and package files together. It has no regulatory value or significance. | string | required : 1 |
Product_NDC | The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. | string | required : 1maxLength : 10 |
Product_Type_Name | Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. | string | required : 1 |
Nonproprietary_Name | Sometimes called the generic name, this is usually the active ingredient(s) of the product. | string | - |
Dosage_Form_Name | The translation of the Dosage Form Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. | string | required : 1 |
Start_Marketing_Date | This is the date that the labeler indicates was the start of its marketing of the drug product | date | - |
End_Marketing_Date | This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the End Marketing Date, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any End Marketing Date. Products with a value in the End Marketing Date will be removed from the NDC Directory when the End Marketing Date is reached. | date | - |
Marketing_Category_Name | Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. | string | required : 1 |
Labeler_Name | Name of Company corresponding to the labeler code segment of the Product NDC | string | required : 1 |
Substance_Name | This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted | string | - |
Active_Numerator_Strength | These are the strength values (to be used with units below) of each active ingredient, listed in the same order as the Substance Name field above. | string | - |
Active_Ingredient_Unit | These are the units to be used with the strength values above, listed in the same order as the Substance Name and Substance Number. | string | - |
DEA_Schedule | This is the assigned Drug Enforcement Administration Schedule number as reported by the labeler. | string | enum : Array ( [0] => CI [1] => CII [2] => CIII [3] => CIV [4] => CV ) maxLength : 4 |
Listing_Record_Certified_Through | The date when the listing record will expire if not updated or certified by the firm. | date | - |
Data Preview
Product ID | Product NDC | Product Type Name | Nonproprietary Name | Dosage Form Name | Start Marketing Date | End Marketing Date | Marketing Category Name | Labeler Name | Substance Name | Active Numerator Strength | Active Ingredient Unit | DEA Schedule | Listing Record Certified Through |
0002-0013_15810e26-b479-41b8-9d13-9dc503a71a2a | 0002-0013 | DRUG FOR FURTHER PROCESSING | Insulin human | INJECTION, SOLUTION | 19830627 | DRUG FOR FURTHER PROCESSING | Eli Lilly and Company | INSULIN HUMAN | 100 | [iU]/mL | 2023-12-31 | ||
0002-0095_15810e26-b479-41b8-9d13-9dc503a71a2a | 0002-0095 | DRUG FOR FURTHER PROCESSING | Insulin human | INJECTION, SOLUTION | 20151229 | DRUG FOR FURTHER PROCESSING | Eli Lilly and Company | INSULIN HUMAN | 500 | [iU]/mL | 2023-12-31 | ||
0002-0096_15810e26-b479-41b8-9d13-9dc503a71a2a | 0002-0096 | DRUG FOR FURTHER PROCESSING | Insulin human | INJECTION, SOLUTION | 19940331 | DRUG FOR FURTHER PROCESSING | Eli Lilly and Company | INSULIN HUMAN | 500 | [iU]/mL | 2023-12-31 | ||
0002-0113_55aa4078-e1e8-4338-b2b5-a9298b3c16e2 | 0002-0113 | DRUG FOR FURTHER PROCESSING | Insulin human | INJECTION, SUSPENSION | 19830627 | DRUG FOR FURTHER PROCESSING | Eli Lilly and Company | INSULIN HUMAN | 100 | [iU]/mL | 2023-12-31 | ||
0002-0119_55aa4078-e1e8-4338-b2b5-a9298b3c16e2 | 0002-0119 | DRUG FOR FURTHER PROCESSING | Insulin human | INJECTION, SUSPENSION | 20131107 | DRUG FOR FURTHER PROCESSING | Eli Lilly and Company | INSULIN HUMAN | 100 | [iU]/mL | 2023-12-31 | ||
0002-0120_ca9c2bc4-15c8-445c-af7e-7980af591db2 | 0002-0120 | DRUG FOR FURTHER PROCESSING | Insulin lispro | INJECTION, SUSPENSION | 19991222 | DRUG FOR FURTHER PROCESSING | Eli Lilly and Company | INSULIN LISPRO | 100 | [iU]/mL | 2023-12-31 | ||
0002-0121_ca9c2bc4-15c8-445c-af7e-7980af591db2 | 0002-0121 | DRUG FOR FURTHER PROCESSING | Insulin lispro | INJECTION, SUSPENSION | 20070906 | DRUG FOR FURTHER PROCESSING | Eli Lilly and Company | INSULIN LISPRO | 100 | [iU]/mL | 2023-12-31 | ||
0002-0124_8d66db15-b010-4799-b0c4-b0758a9e3947 | 0002-0124 | DRUG FOR FURTHER PROCESSING | Insulin lispro | INJECTION, SUSPENSION | 19991222 | DRUG FOR FURTHER PROCESSING | Eli Lilly and Company | INSULIN LISPRO | 100 | [iU]/mL | 2023-12-31 | ||
0002-0137_8d66db15-b010-4799-b0c4-b0758a9e3947 | 0002-0137 | DRUG FOR FURTHER PROCESSING | Insulin lispro | INJECTION, SUSPENSION | 20070906 | DRUG FOR FURTHER PROCESSING | Eli Lilly and Company | INSULIN LISPRO | 100 | [iU]/mL | 2023-12-31 | ||
0002-0485_a30f38b1-df2b-4bad-a9fc-93ca5f77e3dd | 0002-0485 | BULK INGREDIENT | Insulin human | CRYSTAL | 20150401 | BULK INGREDIENT | Eli Lilly and Company | INSULIN HUMAN | 1 | g/g | 2022-12-31 |