Others titles

  • DEA Exemption List
  • SPL Validation Files For DEA Schedule


  • Structured Products Label
  • SPL
  • Drug Dictionary
  • Pharmaceutical Dictionary
  • Drug Names
  • Method Validation
  • Drug Label
  • Drug Enforcement Administration

DEA Exempted Substance Validation Procedure

This dataset is a Structured Product Labeling (SPL) Terminology File for SPL validation procedures and contains information on performing SPL validation regarding DEA (Drug Enforcement Administration) Exempted Substance List.

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Validation procedures can be used by humans as check-lists to verify if their submission is correct. These are written specific and operational so that they may be checked by systems processing SPL documents.

The Validation Procedures for DEA Schedule are as follows:
– If the product item code (NDC) is on the DEA Exempt Products List, then there is no DEA schedule.
– If there is a DEA schedule, then the code system is 2.16.840.1.113883.
– Display name matches the code
– The policy element has a class code of ‘DEADrugSchedule’.
– If the product item code (NDC) is not on the DEA Exempt Products List, then the DEA Schedule matches the one in the Controlled Substance Table where all supplied constraints match.

About this Dataset

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United States


John Snow Labs; US Food & Drug Administration (FDA);

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Structured Products Label, SPL, Drug Dictionary, Pharmaceutical Dictionary, Drug Names, Method Validation, Drug Label, Drug Enforcement Administration

Other Titles

DEA Exemption List, SPL Validation Files For DEA Schedule

Data Fields

Name Description Type Constraints
Type_of_DrugRX (prescription) or AB (bioequivalent) drugstring-
Company_NamePharmaceutical companystring-
Brand_NameCommercial name of drugstring-
NDC_CodeNDC (National Drug Code) product item codestring-
Dosage_FormForm of product presentationstring-
Controlled_Substance_NameName of Controlled substance contained in the productstring-
Controlled_Substance_QuantityQuantity of controlled substance in mg or mg/mlnumberlevel : Ratio
Other_Substance_NameName of ither substance/ingredientstring-
Other_Substance_QuantityAmount of other substance/ingredientstring-

Data Preview

Type of DrugCompany NameBrand NameNDC CodeDosage FormControlled Substance NameControlled Substance QuantityOther Substance NameOther Substance Quantity
RXActavis Pharma, Inc.Butalbital, Acetaminophen and Caffeine Capsules USP 50/300/400591-2640CAButalbital50
RXActavis Pharma, Inc.Butalbital, Acetaminophen and Caffeine Tablets USP 50/325/400591-3369TBButalbital50
RXActavis Pharma, Inc.Fioricet (Butalbital, Acetaminophen and Caffeine USP 50/300/40)52544-080CAButalbital50
RXAlpha Scriptics IncButacet Capsules53121-0133CAButalbital50
RXAlphagen Laboratories, Inc.Butalbital and Acetaminophen Capsules 50mg/ 650mg00603-2542CAButalbital50
RXAlphagen Laboratories, Inc.Donnaphen Tablets59743-0027TBPhenobarbital16
RXAlphagen Laboratories, Inc.Geone Capsules59743-0004CAButalbital50
RXAltana, Inc.Axocet (Butalbital and Acetaminophen)0281-0389TBButalbital50
RXAlthon Pharmaceuticals, Inc.Butalbital, Acetaminophen and Caffeine Tablets USP66813-074TBButalbital50
RXAmerican Pharmaceuticals, Inc.AMERICET Tablets58605-0501TBButalbital50