NDC Products of Unfinished Drugs

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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.

Complexity

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.

Date Created

2012

Last Modified

2018-12-21

Version

2018-12-21

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

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

NameDescriptionTypeConstraints
Product_IDProductID 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.stringrequired : 1
Product_NDCThe 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.stringrequired : 1 maxLength : 10
Product_Type_NameIndicates 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.stringrequired : 1
Nonproprietary_NameSometimes called the generic name, this is usually the active ingredient(s) of the product.string-
Dosage_Form_NameThe 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.stringrequired : 1
Start_Marketing_DateThis is the date that the labeler indicates was the start of its marketing of the drug productdate-
End_Marketing_DateThis 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_NameProduct 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.stringrequired : 1
Labeler_NameName of Company corresponding to the labeler code segment of the Product NDCstringrequired : 1
Substance_NameThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submittedstring-
Active_Numerator_StrengthThese 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_UnitThese 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_ScheduleThis is the assigned Drug Enforcement Administration Schedule number as reported by the labeler.stringenum : Array maxLength : 4
Listing_Record_Certified_ThroughThe date when the listing record will expire if not updated or certified by the firm.date-
Product IDProduct NDCProduct Type NameNonproprietary NameDosage Form NameStart Marketing DateEnd Marketing DateMarketing Category NameLabeler NameSubstance NameActive Numerator StrengthActive Ingredient UnitDEA ScheduleListing Record Certified Through
0002-0485_a30f38b1-df2b-4bad-a9fc-93ca5f77e3dd0002-0485BULK INGREDIENTInsulin humanCRYSTAL2015-04-01BULK INGREDIENTEli Lilly and CompanyINSULIN HUMAN1.0g/g2019-12-31
0002-0535_c7d2c206-601e-4c08-bdea-b6f64167a58b0002-0535BULK INGREDIENTInsulin lisproCRYSTAL2014-01-31BULK INGREDIENTEli Lilly and CompanyINSULIN LISPRO1.0g/g2019-12-31
0002-1401_70b2e81d-fb7e-48bb-b97d-7f2f26f18c410002-1401DRUG FOR FURTHER PROCESSINGDulaglutideINJECTION, SOLUTION2014-09-22DRUG FOR FURTHER PROCESSINGEli Lilly and CompanyDULAGLUTIDE0.75mg/.5mL2019-12-31
0002-1402_70b2e81d-fb7e-48bb-b97d-7f2f26f18c410002-1402DRUG FOR FURTHER PROCESSINGDulaglutideINJECTION, SOLUTION2014-09-22DRUG FOR FURTHER PROCESSINGEli Lilly and CompanyDULAGLUTIDE1.5mg/.5mL2019-12-31
0002-2059_c742fb0d-bd01-471d-8d6d-09f3649c10020002-2059DRUG FOR FURTHER PROCESSINGPemetrexed disodiumINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION2008-01-15DRUG FOR FURTHER PROCESSINGEli Lilly and CompanyPEMETREXED DISODIUM HEPTAHYDRATE100.0mg/4mL2020-12-31
0002-2060_c742fb0d-bd01-471d-8d6d-09f3649c10020002-2060DRUG FOR FURTHER PROCESSINGPemetrexed disodiumINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION2004-02-13DRUG FOR FURTHER PROCESSINGEli Lilly and CompanyPEMETREXED DISODIUM HEPTAHYDRATE500.0mg/20mL2020-12-31
0002-9307_9554755b-bcd5-4266-8cd9-4d6c6723ee0a0002-9307BULK INGREDIENTInsulin humanCRYSTAL1982-10-28BULK INGREDIENTEli Lilly and CompanyINSULIN HUMAN1.0g/g2019-12-31
0002-9524_535e738f-093d-4a1f-9130-590192c8fef10002-9524BULK INGREDIENTInsulin glargineCRYSTAL2014-12-16BULK INGREDIENTEli Lilly and CompanyINSULIN GLARGINE1.0g/g2019-12-31
0004-6941_953a9f8b-6a83-4a76-99e4-bf15b8791c470004-6941DRUG FOR FURTHER PROCESSINGganciclovir sodiumINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION1989-06-23DRUG FOR FURTHER PROCESSINGGenentech, Inc.GANCICLOVIR SODIUM500.0mg/.01kg2018-12-31
0006-0001_1f6ff025-4cdd-46c5-b7b8-d47eded034a20006-0001BULK INGREDIENTsuvorexantTABLET, FILM COATED2014-08-15DRUG FOR FURTHER PROCESSINGMerck Sharp & Dohme Corp.SUVOREXANT5.0mg/12019-12-31