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

2017-10-25

Version

2017-10-25

Update Frequency

Daily

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs => US Food and Drug Administration (FDA)

Source License URL

John Snow Labs Standard License

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

Name Description Type Constraints
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
Product_IDProduct_NDCProduct_Type_NameNonproprietary_NameDosage_Form_NameStart_Marketing_DateEnd_Marketing_DateMarketing_Category_NameLabeler_NameSubstance_NameActive_Numerator_StrengthActive_Ingredient_UnitDEA_Schedule
70716-1777_3372e5c5-aa1f-0c8e-e054-00144ff88e8870716-1777BULK INGREDIENTNeemLIQUID2013-09-05COSMETICBraunfels Labs
70716-194_338336a4-6dec-5fb0-e054-00144ff8d46c70716-194BULK INGREDIENTGlycerinSOAP2014-07-13COSMETICBraunfels Labs
70716-185_39e2bf02-5006-14d1-e054-00144ff8d46c70716-185BULK INGREDIENTGlycerinOINTMENT2014-10-22COSMETICBraunfels Labs
70716-1900_3370f3a4-9d00-4523-e054-00144ff88e8870716-1900BULK INGREDIENTGlycerinOINTMENT2014-10-18COSMETICDavidson, John
70716-1910_39e2e1c0-9e1c-1d5e-e054-00144ff8d46c70716-1910BULK INGREDIENTGlycerinOINTMENT2014-11-20COSMETICBraunfels Labs
70716-1776_3371ac4c-fe90-2f62-e054-00144ff8d46c70716-1776BULK INGREDIENTtea tree oilLIQUID2013-09-05COSMETICBraunfels Labs
70716-7813_39e34ac9-2692-1f0c-e054-00144ff8d46c70716-7813BULK INGREDIENTShea ButterOINTMENT2013-05-30COSMETICBraunfels Labs
64173-202_58b3e880-9897-10bb-e053-2991aa0ac97164173-202BULK INGREDIENTUreaCRYSTAL2017-09-08BULK INGREDIENTBioSpectraUREA1kg/kg
14639-8432_49491831-c9d2-453d-e054-00144ff8d46c14639-8432BULK INGREDIENTUreaPOWDER2016-02-22BULK INGREDIENTMerck KGaAUREA1kg/kg
14639-8432_4af1ff36-115c-0167-e054-00144ff8d46c14639-8432BULK INGREDIENTUreaPOWDER2016-06-15BULK INGREDIENTMerck KGaAUREA1kg/kg