Others titles

  • National Drug Code Directory
  • NDC codes, NDC Products

Keywords

  • NDC Database
  • NDC Lookup
  • NDC Number
  • FDA Product Code

National Drug Code Products

The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution including drug code products. 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.

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Description

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA in SPL electronic listing files by labelers. (A labeler may be either a manufacturer, including a repackager or relabeler, or, for drugs subject to private labeling arrangements, the entity under whose own label or trade name the product will be distributed.) Inclusion of information in the NDC Directory does not indicate that FDA has verified the information provided. The content of each NDC Directory entry is the responsibility of the labeler submitting the SPL file. Assignment of an NDC number does not in any way denote FDA approval of the product. Any representation that creates an impression of official approval because of possession of an NDC number is misleading and constitutes misbranding. (21 CFR 207.39). FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.(See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)).

About this Dataset

Data Info

Date Created

2012

Last Modified

2020-11-12

Version

2020-11-12

Update Frequency

Daily

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

Other Titles

National Drug Code Directory, NDC codes, NDC Products

Data Fields

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 : 1maxLength : 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
Proprietary_NameAlso known as the trade name. It is the name of the product chosen by the labeler.string-
Proprietary_Name_SuffixA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standardstring-
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
Route_NameThe translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resourcesstring-
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
Application_NumberThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.string-
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_Ingred_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-
Pharm_ClassesThese are the reported pharmacological class categories corresponding to the Substance Names listed above.string-
DEA_ScheduleThis is the assigned Drug Enforcement Administration Schedule number as reported by the labeler.stringenum : Array ( [0] => CI [1] => CII [2] => CIII [3] => CIV [4] => CV ) maxLength : 4
Is_NDC_Exclude_FlagThis indicates whether the product has been removed or excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.boolean-
Listing_Record_Certified_ThroughThis is the date when the listing record will expire if not updated or certified by the firmdate-

Data Preview

Product IDProduct NDCProduct Type NameProprietary NameProprietary Name SuffixNonproprietary NameDosage Form NameRoute NameStart Marketing DateEnd Marketing DateMarketing Category NameApplication NumberLabeler NameSubstance NameActive Numerator StrengthActive Ingred UnitPharm ClassesDEA ScheduleIs NDC Exclude FlagListing Record Certified Through
0002-0800_662164fd-5ea0-4a08-bfd1-6b08bdd733420002-0800HUMAN OTC DRUGSterile DiluentdiluentINJECTION, SOLUTIONSUBCUTANEOUS1987-07-10BLABLA018781Eli Lilly and CompanyWATER1.0mL/mLFalse2021-12-31
0002-1200_480fceef-6596-4478-97de-677c155506b30002-1200HUMAN PRESCRIPTION DRUGAmyvidFlorbetapir F 18INJECTION, SOLUTIONINTRAVENOUS2012-06-01NDANDA202008Eli Lilly and CompanyFLORBETAPIR F-1851.0mCi/mLRadioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA]False2021-12-31
0002-1210_151a431b-f07b-4959-b6fa-c41ff80364c80002-1210HUMAN PRESCRIPTION DRUGTAUVIDFlortaucipir F-18INJECTION, SOLUTIONINTRAVENOUS2020-05-28NDANDA212123Eli Lilly and CompanyFLORTAUCIPIR F-1851.0mCi/mLFalse2021-12-31
0002-1433_ac6e0e9f-724c-4c78-823c-cea3ca6c07270002-1433HUMAN PRESCRIPTION DRUGTrulicityDulaglutideINJECTION, SOLUTIONSUBCUTANEOUS2014-09-18BLABLA125469Eli Lilly and CompanyDULAGLUTIDE0.75mg/.5mLGLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]False2022-12-31
0002-1434_ac6e0e9f-724c-4c78-823c-cea3ca6c07270002-1434HUMAN PRESCRIPTION DRUGTrulicityDulaglutideINJECTION, SOLUTIONSUBCUTANEOUS2014-09-18BLABLA125469Eli Lilly and CompanyDULAGLUTIDE1.5mg/.5mLGLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]False2022-12-31
0002-1436_4b767820-97fe-430d-8e77-6047e82ac81e0002-1436HUMAN PRESCRIPTION DRUGEMGALITYgalcanezumab-gnlmINJECTION, SOLUTIONSUBCUTANEOUS2018-09-27BLABLA761063Eli Lilly and CompanyGALCANEZUMAB120.0mg/mLFalse2021-12-31
0002-1445_15a3096a-9d04-4af3-8feb-4df823e6878e0002-1445HUMAN PRESCRIPTION DRUGTALTZixekizumabINJECTION, SOLUTIONSUBCUTANEOUS2016-03-22BLABLA125521Eli Lilly and CompanyIXEKIZUMAB80.0mg/mLInterleukin-17A Antagonist [EPC],Interleukin-17A Antagonists [MoA]False2022-12-31
0002-2236_ac6e0e9f-724c-4c78-823c-cea3ca6c07270002-2236HUMAN PRESCRIPTION DRUGTrulicityDulaglutideINJECTION, SOLUTIONSUBCUTANEOUS2020-09-03BLABLA125469Eli Lilly and CompanyDULAGLUTIDE3.0mg/.5mLGLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]False2022-12-31
0002-2377_4b767820-97fe-430d-8e77-6047e82ac81e0002-2377HUMAN PRESCRIPTION DRUGEMGALITYgalcanezumab-gnlmINJECTION, SOLUTIONSUBCUTANEOUS2018-09-27BLABLA761063Eli Lilly and CompanyGALCANEZUMAB120.0mg/mLFalse2021-12-31
0002-2980_c76a3069-8c7e-4efd-ac8e-a295f77cef890002-2980HUMAN PRESCRIPTION DRUGRETEVMOselpercatinibCAPSULEORAL2020-05-08NDANDA213246Eli Lilly and CompanySELPERCATINIB80.0mg/1Kinase Inhibitor [EPC],Rearranged during Transfection (RET) Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]False2022-12-31