Lot
Distribution Report (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 Column | Field Name | Description |
A | License | License Number |
B | STN | N/A |
C | Product name | Name of Product - Do not mix Products in one Excel Worksheet - Use one Worksheet for each Product |
D | NDC | Product NDC Code - Do not mix Products in one Excel Worksheet - Use one Worksheet for each Product |
E | Container QTY | Quantity of Container - e.g 100, 250 |
F | Container UOM | Unit of Measure for Container - mus match the Unified Code for Units of Measure (UCUM) |
G | Bulk lot ID | Bulk Lot Number |
H | Filling lot ID | Filling Lot Number |
I | Label lot ID | Packagng Lot Number |
J | Quantity distributed | Quantity of Lot Distributed |
K | Quantity returned | Quantity of Lot Returned |
L | Doses per unit | Doses per Lot Unit |
M | Initial distribution date | Intial Distribution Date |
N | Expiration date | Expiration Date |
O | Start date | Report Start Date |
P | End date | Report End Date |
Q | Package lot ID | N/A |
R | Distribution Flag | N/A |
S | Distribution type | N/A |
Lot Distribution Report | ||
Manufacturer DUNS | Company DUNS Number of the Lot Manufacturer | |
Container | The container in which the Product Lots are distributed | |
Active Ingredient | The Active Ingredient in the Product Lots distributed | |
Dosing Specification | Dosing of the distributed Product Lots: Rout of Administration and Dose - Unit Value as Dose can be used - valid SPL is being generated | |
Lot Data | The Lot Data itself - Imported from Excel or manually setup |
Container | ||
Container Form Code | NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function | |
Container Form Display Name | NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function |
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 |
Dosing Specification | ||
Route Of Administration | ||
Dose | Unit Value as Dose can be used - valid SPL is being generated |
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 |
Dose | ||
Value | Number 1,2,3 etc. | |
Unit | Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details |
Lot Data | ||
Filling Lot | Filling Lot Information |
Filling Lot | ||
OID | The 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 Number | The Filling Lot Number | |
Bulk Lot | Bulk Lot Information | |
Label Lot | Label Lot Information |
Bulk Lot | ||
OID | The 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 Number | The Bulk Lot Number | |
Manufacturer DUNS | Company DUNS Number of the Lot Manufacturer | |
Active Ingredient |
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 |
Label Lot | ||
OID | The 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 Number | The Label Lot Number | |
Expiry Date | Lot Expriy Date | |
Container | Lot Container Information - inherited from Lot Distribution Report general settings on Excel Import | |
Quantity Distributed | Lot Quantity Distributed | |
Quantity Returned | Lot Quantity Returned |
Container | ||
NDC Code | ||
Container Form Code | NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function | |
Container Form Display Name | NCI National Cancer Institute Thesaurus - Select from List or Use FDA SPL Software Search Function | |
Quantity |
Quantity | ||
Value | Number 1,2,3 etc. | |
Unit | Unified Code for Units of Measure (UCUM) - check http://www.fda.gov for details |
Quantity Distributed | ||
Units | ||
Initial Distribution Date | Initial Distribution Date |
Quantity Returned | ||
Units |