Labeler, Registrant and Establishment Information
FDA SPL for SPL R4 - Structured Product Labeling - User Manual

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Depending on the Document Type being created, Labeler, Registrant, Establishment US Agent and Import information can be added to the SPL file.

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

LabelerLabeler information and all its dependent company data such as registrant, manufacturer, us agent etc.
Company NameCompany name of the labeling firm
DUNS NumberLabeler Dun and Bradstreet Number - check http://www.dnb.com/us/ for details
NDC Labeler CodeNational Drug Code Directory - code of the labeling company - check http://www.fda.gov for details
Labeler ContactLabeler contact information
RegistrantRegistration holder company and contact information

 

Labeler ContactLabeler contact information
AddressStreet name and -number
City
StateUS State if applicable, else to be removed
Postal Code
CountryISO 3166-1 Alpha-3 Country Code
Phone
Email
Contact Person Name

 

RegistrantRegistration holder company and contact information
Company NameCompany name of the registration holder
DUNS NumberRegistration holder Dun and Bradstreet Number - check http://www.dnb.com/us/ for details
ConfidentialityB=Business Confidentiality - if not confidential then remove information
Registrant ContactRegistration holder contact
EstablishmentEstablishment information of company involved in the marketing process

 

Registrant ContactRegistration holder contact
AddressStreet name and -number
City
StateUS State if applicable, else to be removed
Postal Code
CountryISO 3166-1 Alpha-3 Country Code
Phone
Email
Contact Person Name

 

EstablishmentEstablishment information of company involved in the marketing process
Company NameCompany name of the establishment involved in the marketing process
DUNS NumberEstablishment Dun and Bradstreet Number - check http://www.dnb.com/us/ for details
FDA Establishment IdentifierFDA Establishment Identifier - check http://www.fda.gov for details
ConfidentialityB=Business Confidentiality - if not confidential then remove information
Business Operation CodeUNII Code for Establishment Business Operation, select from list or use FDA provided values
Business Operation Display NameUNII Display Name for Business Operation, Establishment Business Operation, select from list or use FDA provided values
Establishment AddressAddress of the establishment involved in the marketing process
Establishment ContactContact details of the establishment involved in the marketing process
US AgentUS Agent involved in the marketing process
ImporterCompany information which is importing to the USA

 

Establishment AddressAddress of the establishment involved in the marketing process
AddressStreet name and -number
City
StateUS State if applicable, else to be removed
Postal Code
CountryISO 3166-1 Alpha-3 Country Code of the Establishment

 

Establishment ContactContact details of the establishment involved in the marketing process
AddressStreet name and -number
City
StateUS State if applicable, else to be removed
Postal Code
CountryISO 3166-1 Alpha-3 Country Code the Establishment Contact
Phone
Email
Contact Person Name

 

US AgentUS Agent involved in the marketing process
Company NameCompany name of the US agent involved in the marketing process
DUNS NumberUS agent Dun and Bradstreet Number - check http://www.dnb.com/us/ for details
AddressStreet name and -number
City
StateUS State
Postal Code
CountryISO 3166-1 Alpha-3 Country Code
Phone
Email

 

ImporterCompany information which is importing to the USA
Company NameCompany name of the Importing firm involved in the marketing process
DUNS NumberImporting firm Dun and Bradstreet Number - check http://www.dnb.com/us/ for details
Address
City
StateUS State
Postal Code
CountryISO 3166-1 Alpha-3 Country Code of the Importing firm
Phone
Email

 

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