This SPL R4 Document Part allows coding of Product Listing Information such as Product Name, Active and Inactive Ingredients, Packaging, Characteristics etc.

See FDA SPL Online Resources for more information under:
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm

	Products
	GUID	Unique Identifier for product listing
	Effective Time	Product listing date YYYYDDMM Date Format - 20090101
	Product	Detailed Product information including Proprietary Name, Ingredients, Packaging, Marketing Information and characteristics

	Product
	Kit Assembly	Drug Kit information according to FDA CBER and CDER
	Drug Product	Drug product information according to FDA CBER and CDER
	Device Product	Medical Device information - NHRIC - National Health Related Items Code
	Source Drug Product	Source Product information for generics
	Marketing Category	FDA marketing authorization information
	Active Marketing Status
	Inactive Marketing Status
	DEA Schedule	Drug Enforcement Agency Information
	Product Characteristics	Characteristics such as shape, color, flavor, size, administration
	Lot Distribution Report	The Lot Distribution Report for Product - Import From Excel

	Kit Assembly
	NDC Product Code	NDC - National Drug Code Directory - check http://www.fda.gov for details
	Proprietary Name	Product name as marketed
	Suffix	Suffix to be placed under the product name
	Dosage Form Code	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function or select from list
	Dosage Form Display Name	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Generic Medicine Name	Name of the generic if any
	Kit Component
	Packaging	Product Packaging information

	Kit Component
	NDC Product Code	NDC - National Drug Code Directory - check http://www.fda.gov for details
	Proprietary Name	Product name as marketed
	Suffix	Suffix to be placed under the product name
	Generic Medicine Name	Name of the generic if any
	Dosage Form Code	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function or select from list
	Dosage Form Display Name	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Denominator Value	Number 1,2,3 etc.
	Route Of Administration
	Ingredients	Active- and Inactive Ingredients, Moiety and Reference Drug information if any
	Packaging	Product Packaging information
	Marketing Category	FDA marketing authorization information
	Active Marketing Status
	Inactive Marketing Status
	DEA Schedule	Drug Enforcement Agency Information

	Route Of Administration
	NCI Code	Administrative route code of the product from NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	NCI Display Name	Administrative route name of the product from NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function

	Ingredients
	Active Ingredient
	Active Moiety
	Inactive Ingredient
	Reference Drug

	Active Ingredient
	Ingredient Name	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Ingredient UNII Code	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Moiety Name	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Moiety UNII Code	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Denominator Value	Number 1,2,3 etc.
	Quantity Denominator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details

	Active Moiety
	Ingredient Name	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Ingredient UNII Code	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Moiety Name	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Moiety UNII Code	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Denominator Value	Number 1,2,3 etc.
	Quantity Denominator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details

	Inactive Ingredient
	Confidentiality	B=Business Confidentiality - if not confidential then remove information
	Ingredient Name	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Ingredient UNII Code	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Denominator Value	Number 1,2,3 etc.
	Quantity Denominator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details

	Reference Drug
	Ingredient Name	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Ingredient UNII Code	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Moiety Name	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Moiety UNII Code	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Reference Drug Name	Name/code of the reference drug according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Reference Drug UNII Code	Name/code of the reference drug according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Denominator Value	Number 1,2,3 etc.
	Quantity Denominator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details

	Packaging
	NDC Packager Code	National Drug Code Directory - check http://www.fda.gov for details
	Packaging Form Code	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Packaging Form Display Name	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Numerator Translation Code	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Quantity Numerator Translation Display Name	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Quantity Denominator	Number 1,2,3 etc.

	Marketing Category
	Application Or Monograph Number	Registration Number of the Product or Monograph Number according to FDA - check http://www.fda.gov for details
	NCI Marketing Category Code	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	NCI Marketing Category Display Name	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Territorial Authority

	Active Marketing Status
	Date On Market	First Market Date YYYYDDMM Date Format - 20090101

	Inactive Marketing Status
	Date On Market	First Market Date YYYYDDMM Date Format - 20090101
	Date Off Market	Last Market Date YYYYDDMM Date Format - 20090101

	DEA Schedule
	NCI Code	Drug Enforcement Agency - Code for Schedule - source: NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	NCI Display Name	Drug Enforcement Agency - Name for Schedule - source: NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function

	Packaging
	NDC Packager Code	National Drug Code Directory - check http://www.fda.gov for details
	Packaging Form Code	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Packaging Form Display Name	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Numerator Translation Code	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Quantity Numerator Translation Display Name	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Quantity Denominator	Number 1,2,3 etc.
	Combination Product Type Code	Combined Product Types - Codes from NCI Thesaurus
	Combination Product Type Name	Combined Product Types - Acceptable Terms from NCI Thesaurus
	Container	Container Packaged Products - where the packaging is contained. NDC Packager Code, Packaging Form Code, Packaging Form Display Name, Quantity Numerator Value, Quantity Numerator Unit, Quantity Denominator.

	Drug Product
	NDC Product Code	NDC - National Drug Code Directory - check http://www.fda.gov for details
	Proprietary Name	Product name as marketed
	Suffix	Suffix to be placed under the product name
	Dosage Form Code	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function or select from list
	Dosage Form Display Name	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Generic Medicine Name	Name of the generic if any
	Ingredients	Active- and Inactive Ingredients, Moiety and Reference Drug information if any
	Packaging	Product Packaging information

	Ingredients
	Active Ingredient
	Active Moiety
	Inactive Ingredient
	Reference Drug

	Active Ingredient
	Ingredient Name	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Ingredient UNII Code	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Moiety Name	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Moiety UNII Code	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Denominator Value	Number 1,2,3 etc.
	Quantity Denominator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details

	Active Moiety
	Ingredient Name	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Ingredient UNII Code	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Moiety Name	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Moiety UNII Code	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Denominator Value	Number 1,2,3 etc.
	Quantity Denominator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details

	Inactive Ingredient
	Confidentiality	B=Business Confidentiality - if not confidential then remove information
	Ingredient Name	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Ingredient UNII Code	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Denominator Value	Number 1,2,3 etc.
	Quantity Denominator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details

	Reference Drug
	Ingredient Name	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Ingredient UNII Code	Name/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Moiety Name	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Moiety UNII Code	Name/code of the Moiety according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Reference Drug Name	Name/code of the reference drug according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Reference Drug UNII Code	Name/code of the reference drug according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Denominator Value	Number 1,2,3 etc.
	Quantity Denominator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details

	Packaging
	NDC Packager Code	National Drug Code Directory - check http://www.fda.gov for details
	Packaging Form Code	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Packaging Form Display Name	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Numerator Translation Code	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Quantity Numerator Translation Display Name	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Quantity Denominator	Number 1,2,3 etc.

	Device Product
	NHRIC Product Code	NHRIC - National Health Related Items Code
	Proprietary Name
	Suffix
	Device Code
	Device Code System
	Device Display Name
	Device Description
	Lot Number
	Model Name Or Serial Number
	Ingredients
	Packaging
	Assembly With Other Product
	Assembly As Kit

	Ingredients
	Ingredient

	Ingredient
	Ingredient Name	UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Ingredient UNII Code	UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Denominator Value	Number 1,2,3 etc.
	Quantity Denominator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details

	Packaging
	NDC Packager Code	National Drug Code Directory - check http://www.fda.gov for details
	Packaging Form Code	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Packaging Form Display Name	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Numerator Translation Code	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Quantity Numerator Translation Display Name	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Quantity Denominator	Number 1,2,3 etc.

	Assembly With Other Product
	Name
	OID Code

	Assembly As Kit
	Name
	OID Code

	Source Drug Product
	NDC Product Code	NDC - National Drug Code Directory - check http://www.fda.gov for details
	Proprietary Name
	Suffix
	Source NDC Product Code
	Packaging

	Packaging
	NDC Packager Code	National Drug Code Directory - check http://www.fda.gov for details
	Packaging Form Code	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Packaging Form Display Name	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Quantity Numerator Value	Number 1,2,3 etc.
	Quantity Numerator Unit	Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details
	Quantity Numerator Translation Code	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Quantity Numerator Translation Display Name	NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Quantity Denominator	Number 1,2,3 etc.

	Marketing Category
	Application Or Monograph Number	Registration Number of the Product or Monograph Number according to FDA - check http://www.fda.gov for details
	NCI Marketing Category Code	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	NCI Marketing Category Display Name	NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Territorial Authority

	Active Marketing Status
	Date On Market	First Market Date YYYYDDMM Date Format - 20090101

	Inactive Marketing Status
	Date On Market	First Market Date YYYYDDMM Date Format - 20090101
	Date Off Market	Last Market Date YYYYDDMM Date Format - 20090101

	DEA Schedule
	NCI Code	Drug Enforcement Agency - Code for Schedule - source: NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	NCI Display Name	Drug Enforcement Agency - Name for Schedule - source: NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function

	Product Characteristics
	General
	Color
	Shape
	Size
	Flavor
	Contains
	Sterilization
	Route Of Administration

	General
	Imprint	Characteristics to describe the appearance of the drug product
	Score Value	In how many pieces a tablet can be broken - Number 1,2,3 etc.
	Image	Browse for Image File - Image will be copied to location where SPL file is saved

	Color
	NCI Code	Color Code from NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	NCI Display Name	Color Display Name from NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Descriptive Text	An additional non coded text for color description

	Shape
	NCI Code	Shape Display Name deriving from NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	NCI Display Name	Shape Display Name deriving from NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Descriptive Text

	Size
	Value	Size of the tablet or capsule Number 1,2,3 etc.
	Unit	Unit for size value derived from Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details

	Flavor
	NCI Code	Flavor code from NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	NCI Display Name	Flavor Display Name from NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	Descriptive Text

	Contains
	NCI Code	Product contained information code from NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	NCI Display Name	Product contained information name from NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Descriptive Text	An additional non coded text for contains description

	Sterilization
	NCI Code	How sterilization is applied - code from NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	NCI Display Name	How sterilization is applied - name from NCI National Cancer Institute Thesaurus - Use FDA SPL Software Search Function
	Number Of Usages	Number of usages: 1,2,3 etc.

	Route Of Administration
	NCI Code	Administrative route code of the product from NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
	NCI Display Name	Administrative route name of the product from NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function

(c) sartori-software.com 2018