Further Details on using CSV Files

Ed Hallissey

Project Manager, CARES system

Office of Business Informatics

CDER | US FDA

Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act –

September 8, 2022
www.fda.gov 2

Overview

• CSV Format and Examples

• Common CSV Errors

• Resources
www.fda.gov 3

Establishment 

DUNS

Business

Operation NDC

Source 

NDC Volume Per

Outermost 

Quantity

Released

Outermost Quantity

Distributed (Non-US)

Outermost 

Package

Type

Innermost 

Quantity

Released

Innermost Quantity

Distributed (Non-US)

Innermost 

Package Type

Market 

Unknown

111111111 Manufacture 1234-1234-12 January 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 February 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 March 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 April 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 May 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 June 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 July 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 August 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 September 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 October 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 November 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 December 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12

Annual 

Total 1250 600CASE 12500 3000BLISTER PACK No
www.fda.gov 4

Establishment 

DUNS

Business 

Operation NDC

Source 

NDC Volume Per

Outermost 

Quantity 

Released

Outermost Quantity 

Distributed (Non-US)

Outermost 

Package 

Type

Innermost 

Quantity 

Released

Innermost Quantity 

Distributed (Non-US)

Innermost 

Package Type

Market 

Unknown

111111111 Manufacture 1234-1234-12 January 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 February 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 March 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 April 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 May 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 June 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 July 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 August 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 September 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 October 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 November 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 December 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12

Annual 

Total 1250 600CASE 12500 3000BLISTER PACK No
www.fda.gov 5

Establishment 

DUNS

Business 

Operation NDC

Source 

NDC Volume Per

Outermost 

Quantity 

Released

Outermost Quantity 

Distributed (Non-US)

Outermost 

Package 

Type

Innermost 

Quantity 

Released

Innermost Quantity 

Distributed (Non-US)

Innermost 

Package Type

Market 

Unknown

111111111 Manufacture 1234-1234-12 January 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 February 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 March 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 April 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 May 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 June 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 July 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 August 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 September 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 October 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 November 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 December 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12

Annual 

Total 1250 600CASE 12500 3000BLISTER PACK No
www.fda.gov 6

Establishment 

DUNS

Business

Operation NDC

Source

NDC

Volume

Per

Outermost 

Quantity 

Released

Outermost Quantity 

Distributed (Non-US)

Outermost 

Package

Type

Innermost 

Quantity 

Released

Innermost Quantity 

Distributed (Non-US)

Innermost 

Package Type

Market 

Unknown

111111111 Manufacture 1234-1234-12 January 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 February 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 March 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 April 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 May 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 June 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 July 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 August 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 September 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 October 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 November 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 December 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12

Annual

Total 1250 600CASE 12500 3000BLISTER PACK No

111111111 API Manufacture 12345-1234-1 January 200 450CONTAINER No

111111111 API Manufacture 12345-1234-1 February 250 450CONTAINER No

111111111 API Manufacture 12345-1234-1 March 250 450CONTAINER No

111111111 API Manufacture 12345-1234-1 April 650 0CONTAINER No

111111111 API Manufacture 12345-1234-1 May 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 June 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 July 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 August 650 0CONTAINER No

111111111 API Manufacture 12345-1234-1 September 650 0CONTAINER No

111111111 API Manufacture 12345-1234-1 October 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 November 325 450CONTAINER No

111111111 API Manufacture 12345-1234-1 December 325 450CONTAINER No

111111111 API Manufacture 12345-1234-1

Annual 

Total 3300 2250CONTAINER No
www.fda.gov 7

Establishment 

DUNS

Business

Operation NDC

Source

NDC

Volume

Per

Outermost 

Quantity 

Released

Outermost Quantity 

Distributed (Non-US)

Outermost 

Package

Type

Innermost 

Quantity 

Released

Innermost Quantity 

Distributed (Non-US)

Innermost 

Package Type

Market 

Unknown

111111111 Manufacture 1234-1234-12 January 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 February 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 March 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 April 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 May 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 June 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 July 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 August 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 September 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 October 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 November 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 December 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12

Annual

Total 1250 600CASE 12500 3000BLISTER PACK No

111111111 API Manufacture 12345-1234-1 January 200 450CONTAINER No

111111111 API Manufacture 12345-1234-1 February 250 450CONTAINER No

111111111 API Manufacture 12345-1234-1 March 250 450CONTAINER No

111111111 API Manufacture 12345-1234-1 April 650 0CONTAINER No

111111111 API Manufacture 12345-1234-1 May 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 June 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 July 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 August 650 0CONTAINER No

111111111 API Manufacture 12345-1234-1 September 650 0CONTAINER No

111111111 API Manufacture 12345-1234-1 October 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 November 325 450CONTAINER No

111111111 API Manufacture 12345-1234-1 December 325 450CONTAINER No

111111111 API Manufacture 12345-1234-1

Annual 

Total 3300 2250CONTAINER No
www.fda.gov 8

Establishment 

DUNS

Business

Operation NDC

Source

NDC

Volume

Per

Outermost 

Quantity 

Released

Outermost Quantity 

Distributed (Non-US)

Outermost 

Package

Type

Innermost 

Quantity 

Released

Innermost Quantity 

Distributed (Non-US)

Innermost 

Package Type

Market 

Unknown

111111111 Manufacture 1234-1234-12 January 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 February 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 March 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 April 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 May 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 June 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 July 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 August 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 September 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 October 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 November 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 December 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12

Annual

Total 1250 600CASE 12500 3000BLISTER PACK No

111111111 API Manufacture 12345-1234-1 January 200 450CONTAINER No

111111111 API Manufacture 12345-1234-1 February 250 450CONTAINER No

111111111 API Manufacture 12345-1234-1 March 250 450CONTAINER No

111111111 API Manufacture 12345-1234-1 April 650 0CONTAINER No

111111111 API Manufacture 12345-1234-1 May 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 June 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 July 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 August 650 0CONTAINER No

111111111 API Manufacture 12345-1234-1 September 650 0CONTAINER No

111111111 API Manufacture 12345-1234-1 October 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 November 325 450CONTAINER No

111111111 API Manufacture 12345-1234-1 December 325 450CONTAINER No

111111111 API Manufacture 12345-1234-1

Annual 

Total 3300 2250CONTAINER No
www.fda.gov 9

Establishment DUNS Business Operation NDC Source NDC Volume Per

Outermost Quantity 

Released

Outermost Quantity Distributed 

(Non-US)

Outermost Package

Type

Innermost Quantity 

Released

Innermost Quantity Distributed 

(Non-US)

Innermost Package

Type

Market 

Unknown

111111111 Manufacture 1234-1234-12 January 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 February 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 March 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 April 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 May 100 50CASE 1000 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 June 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 July 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 August 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 September 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 October 150 50CASE 1500 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 November 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 December 0 50CASE 0 250BLISTER PACK No

111111111 Manufacture 1234-1234-12 Annual Total 1250 600CASE 12500 3000BLISTER PACK No

111111111 API Manufacture 12345-1234-1 January 200 450CONTAINER No

111111111 API Manufacture 12345-1234-1 February 250 450CONTAINER No

111111111 API Manufacture 12345-1234-1 March 250 450CONTAINER No

111111111 API Manufacture 12345-1234-1 April 650 0CONTAINER No

111111111 API Manufacture 12345-1234-1 May 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 June 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 July 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 August 650 0CONTAINER No

111111111 API Manufacture 12345-1234-1 September 650 0CONTAINER No

111111111 API Manufacture 12345-1234-1 October 0 0CONTAINER No

111111111 API Manufacture 12345-1234-1 November 325 450CONTAINER No

111111111 API Manufacture 12345-1234-1 December 325 450CONTAINER No

111111111 API Manufacture 12345-1234-1 Annual Total 3300 2250CONTAINER No

222222222 Transfill 12345-123-12 January 600 100BAG Yes

222222222 Transfill 12345-123-12 February 0 90BAG Yes

222222222 Transfill 12345-123-12 March 0 100BAG Yes

222222222 Transfill 12345-123-12 April 0 100BAG Yes

222222222 Transfill 12345-123-12 May 100 100BAG Yes

222222222 Transfill 12345-123-12 June 0 0BAG Yes

222222222 Transfill 12345-123-12 July 0 100BAG Yes

222222222 Transfill 12345-123-12 August 0 0BAG Yes

222222222 Transfill 12345-123-12 September 700 0BAG Yes

222222222 Transfill 12345-123-12 October 0 0BAG Yes

222222222 Transfill 12345-123-12 November 0 400BAG Yes

222222222 Transfill 12345-123-12 December 900 0BAG Yes

222222222 Transfill 12345-123-12 Annual Total 2300 990BAG Yes
www.fda.gov 10

111111111,Manufacture,1234-1234-12,,January,100,50,CASE,1000,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,February,100,50,CASE,1000,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,March,100,50,CASE,1000,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,April,100,50,CASE,1000,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,May,100,50,CASE,1000,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,June,150,50,CASE,1500,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,July,150,50,CASE,1500,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,August,150,50,CASE,1500,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,September,150,50,CASE,1500,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,October,150,50,CASE,1500,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,November,0,50,CASE,0,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,December,0,50,CASE,0,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,Annual Total,1250,600,CASE,12500,3000,BLISTER PACK,No

111111111,API Manufacture,12345-1234-1,,January,200,450,CONTAINER,,,,No

111111111,API Manufacture,12345-1234-1,,February,250,450,CONTAINER,,,,No

111111111,API Manufacture,12345-1234-1,,March,250,450,CONTAINER,,,,No

111111111,API Manufacture,12345-1234-1,,April,650,0,CONTAINER,,,,No

111111111,API Manufacture,12345-1234-1,,May,0,0,CONTAINER,,,,No

111111111,API Manufacture,12345-1234-1,,June,0,0,CONTAINER,,,,No

111111111,API Manufacture,12345-1234-1,,July,0,0,CONTAINER,,,,No

111111111,API Manufacture,12345-1234-1,,August,650,0,CONTAINER,,,,No

111111111,API Manufacture,12345-1234-1,,September,650,0,CONTAINER,,,,No

111111111,API Manufacture,12345-1234-1,,October,0,0,CONTAINER,,,,No

111111111,API Manufacture,12345-1234-1,,November,325,450,CONTAINER,,,,No

111111111,API Manufacture,12345-1234-1,,December,325,450,CONTAINER,,,,No

111111111,API Manufacture,12345-1234-1,,Annual Total,3300,2250,CONTAINER,,,,No
www.fda.gov 11

Common Parsing Errors

• The system will parse data using a comma “,” as the field delimiter.

Please ensure there are no commas within the values in the csv file.

For example, replace CASE,"1,000",250 with CASE,1000,250

• Replace all semicolons “;” field delimiters with commas ”,”

• Remove all empty lines at the end of the csv file containing commas

• Quotation marks should be excluded

• The system will only accept files with lower case “.csv”

• \n,\r,\r\n are all acceptable end of line (EOL) characters

• No specific file encoding is enforced. Default and UTF-8 are both

acceptable
www.fda.gov 12

111111111,Manufacture,1234-1234-12,,January,100,50,CASE,”1,000”,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,February,100,50,CASE,1000,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,March,100,50,CASE,1000,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,April,100,50,CASE,1000,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,May,100,50,CASE,1000,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,June,150,50,CASE,1500,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,July,150,50,CASE,1500,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,August,150,50,CASE,1500,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,September,150,50,CASE,1500,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,October,150,50,CASE,1500,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,November,0,50,CASE,0,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,December,0,50,CASE,0,250,BLISTER PACK,No

111111111,Manufacture,1234-1234-12,,Annual Total;1250,600;CASE;12500;3000;BLISTER PACK;No

111111111,API Manufacture,12345-1234-1,,January,200,450,CONTAINER,,,No

111111111,API Manufacture,12345-1234-1,,February,250,450,CONTAINER,,,No

111111111,API Manufacture,12345-1234-1,,March,250,450,CONTAINER,,,No

111111111,API Manufacture,12345-1234-1,,April,650,0,CONTAINER,,,No

111111111,API Manufacture,12345-1234-1,,May,0,0,CONTAINER,,,No

111111111,API Manufacture,12345-1234-1,,June,0,0,CONTAINER,,,No

111111111,API Manufacture,12345-1234-1,,July,0,0,CONTAINER,,,No

111111111,API Manufacture,12345-1234-1,,August,650,0,CONTAINER,,,No

111111111,API Manufacture,12345-1234-1,,September,650,0,CONTAINER,,,No

111111111,API Manufacture,12345-1234-1,,October,0,0,CONTAINER,,,No

111111111,API Manufacture,12345-1234-1,,November,325,450,CONTAINER,,,No

111111111,API Manufacture,12345-1234-1,,December,325,450,CONTAINER,,,No

111111111,API Manufacture,12345-1234-1,,Annual Total,3300,2250,CONTAINER,,,No
www.fda.gov 13

Do I need to return to the CDER NextGen 

Portal after I have made my submission ?

• Once a submission is made, the system is verifying the details of your

submission.

• If the system determines there is an error, then you will be alerted via

email that further actions are required – then you must return to the

Portal to correct the error and/or take further action.

• If there are no concerns with the submission, you will receive a

confirmation email of successful submission. You do not need to take

further action. If you return to the Portal, it will indicate successful

submission.
www.fda.gov 14