Lot Distribution Report
FDA SPL for SPL R4 - Structured Product Labeling - User Manual

(c) sartori-software.com 2015

Lot Distrubtion Report is defined on Product Level

To import Lot Distribution Report from Excel, select the Lot Distribution Report Node, then on Menu "SPL Document" -> "Import from Excel"

Select Excel File, and Worksheet to Import.

Note: If you want to skip data from the Worksheet, Use the Excel "Hide" function. Make sure you save the latest version of your Excel File before starting import

Expected Excel Format:

Excel ColumnField NameDescription
ALicenseLicense Number
BSTNN/A
CProduct nameName of Product - Do not mix Products in one Excel Worksheet - Use one Worksheet for each Product
DNDC Product NDC Code - Do not mix Products in one Excel Worksheet - Use one Worksheet for each Product
EContainer QTYQuantity of Container - e.g 100, 250
FContainer 
UOM
Unit of Measure for Container - mus match the Unified Code for Units of Measure (UCUM) 
GBulk lot IDBulk Lot Number
HFilling lot IDFilling Lot Number
ILabel lot IDPackagng Lot Number
J Quantity distributedQuantity of Lot Distributed
KQuantity returnedQuantity of Lot Returned
LDoses per unitDoses per Lot Unit
MInitial distribution
date
Intial Distribution Date
NExpiration dateExpiration Date
OStart dateReport Start Date
PEnd dateReport End Date
QPackage lot IDN/A
RDistribution FlagN/A
SDistribution typeN/A


Lot Distribution Report
Manufacturer DUNSCompany DUNS Number of the Lot Manufacturer
ContainerThe container in which the Product Lots are distributed
Active IngredientThe Active Ingredient in the Product Lots distributed
Dosing SpecificationDosing of the distributed Product Lots: Rout of Administration and Dose - Unit Value as Dose can be used - valid SPL is being generated
Lot DataThe Lot Data itself - Imported from Excel or manually setup


Container
Container Form CodeNCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
Container Form Display NameNCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function


Active Ingredient
Ingredient NameName/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
Ingredient UNII CodeName/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function


Dosing Specification
Route Of Administration
DoseUnit Value as Dose can be used - valid SPL is being generated


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


Dose
ValueNumber 1,2,3 etc.
UnitUnified Code for Units of Measure (UCUM) - check http://www.fda.gov for details


Lot Data
Filling LotFilling Lot Information


Filling Lot
OIDThe Filling Lot OID is formed by using the fixed prefix 1.3.6.1.4.1.32366.1.2.10. followed by the NDC product code without dashes and without leading zeroes
Lot NumberThe Filling Lot Number
Bulk LotBulk Lot Information
Label LotLabel Lot Information


Bulk Lot
OIDThe Bulk Lot OID is formed by using the fixed prefix “1.3.6.1.4.1.32366.1.2.10.” followed by the NDC Labeler Code without leading zeroes.
Lot NumberThe Bulk Lot Number
Manufacturer DUNSCompany DUNS Number of the Lot Manufacturer
Active Ingredient


Active Ingredient
Ingredient NameName/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function
Ingredient UNII CodeName/code of the ingredient according to UNII - FDA Unique identifiers for ingredients - Use FDA SPL Software Search Function


Label Lot
OIDThe Label Lot OID is formed by using the fixed prefix “1.3.6.1.4.1.32366.1.2.10.” followed by the full 10-digit NDC code without dashes or leading zeroes.
Lot NumberThe Label Lot Number
Expiry DateLot Expriy Date
ContainerLot Container Information - inherited from Lot Distribution Report general settings on Excel Import
Quantity DistributedLot Quantity Distributed
Quantity ReturnedLot Quantity Returned


Container
NDC Code
Container Form CodeNCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
Container Form Display NameNCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function
Quantity


Quantity
ValueNumber 1,2,3 etc.
UnitUnified Code for Units of Measure (UCUM) - check http://www.fda.gov for details


Quantity Distributed
Units
Initial Distribution DateInitial Distribution Date


Quantity Returned
Units


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