US FDA recommended on 25 July 2022, revision in the format of NDC. I have summarized the proposed rule in simplest of manners for ease of understanding.

1. Proposed Rule on Revising the
National Drug Code Format
Sunil Tekwani, ProductLife Group

2. What is an NDC number?
• A unique 3 segment number
• Contains total 10 digits
• Printed on all drug labels in US market
• Identifier of drugs, marketed in US
• It can be in the following 3 formats:
Eg. For Pfizer’s Norvasc tablets packed in 90’s container it is:
0069-1520-68. So it’s a 4-4-2 format.
4-4-2 5-3-2 5-4-1

3. NDC number
GTIN number

4. In this example of Norvasc
NDC number: 0069-1520-68 (4-4-2 format)
• 0069 - Labeler code; which is issued by FDA to a specific manufacturer or entity. So 0069 is specific for all Pfizer
products. Manufacturer has to request labeler code from FDA via NextGen Portal.
• For every entity/manufacturer there is a unique labeler code.
• 1520 - Product code; which is given by the manufacturer. So Pfizer has given 1520 to it’s amlodipine tablets.
• 68 - Package code; which is given by the manufacturer to a specific SKU. In this case, 68 is given to 90 tablets
container.

5. Soon 5 digit Labeler codes will exhaust…
• Out of the 3 segments, FDA only issues the labeler code, while product code and
package code have to be given by the manufacturer according to their internal system.
• FDA issued 4 digit labeler codes previously and now issues 5 digit labeler codes, as 4
digit codes are exhausted.
• 5 digit codes are issued from 10000 to 99999, that means FDA has a total of 90000
labeler codes available for issue.
• FDA estimates that 5 digit codes will exhaust in coming 10-15 years because number of
labelers are increasing drastically

6. 6 digit labeler codes:
• In 2016 rule, agency stated that it will start issuing 6 digit labeler codes after 5 digit codes
are exhausted.
• So there will be three 10 digit configurations and two 11 digit configurations.
Existing NDC formats If 6 digit labeler code comes to effect
4-4-2, 5-4-1, 5-3-2 4-4-2, 5-4-1, 5-3-2, 6-4-1, 6-3-2
total configurations: 3 Total configurations: 5

7. So what’s the issue with these five possible
configurations?
• HIPAA-- The Health Insurance Portability and Accountability Act
• According to this act, drugs are tracked through NDC number in all insurance related
transactions.
• But in these transactions, 10 digit NDC is converted to 11 digit NDC in 5-4-2 format by
adding leading “Zeros”
• Example:
Actual NDC HIPAA NDC
0069-1520-68 00069152068

8. If there is 6 digit labeler code
• HIPAA’s acceptable format of 5-4-2 can not be attained.

9. Hence a uniform 12 digit format is proposed.
• 6-4-2
• Which will be adopted by FDA and HIPAA both.

10. What is the main challenge with this new
proposed 12 digit format?
The main challenge is the GTIN 14 data standard
The GTIN is a globally unique 14-digit number used to identify trade items, products, or
services.
This number is printed on all US labels. refer slide 3 to see how GTIN number is reflected on the
labels.
This GTIN can accommodate only 10-digit NDC number
To accommodate 12-digit NDC, a new data standard would be required.

11. Timelines for the
proposed rule

12. Comments from stakeholders
5 years
3 years transition phase
FDA starts issuing 6 digit labeler codes+
FDA converts existing 10 digit NDCs to new
12 digit format by adding leading zeros.
All marketed products
must have 12 digit NDC
on the labels
Rule Effective
Proposed rule
Publishing of rule

13. What should manufacturers do with existing 10 digit
NDCs?
So, to reduce the burden on manufacturers, when the rule will be effective after 5 years:
FDA itself will convert the 10 digit codes to 12 digits by adding leading zeros and publish on it’s listing.
Example:
Manufacturers can use this 12 digit format in next drug listing and submit the update labels in their next annual
reports.
During transition period of 3 years, drugs with 10 digits NDC can still be distributed in US market
Existing code on NDC
directory
During transition phase of
3 years
Note
0069-1520-68 0069-1520-68
000069-1520-68
Both 10 digit and 12 digit will reflect on
directory during 3 year transition.

14. Why is there a 5 year effectiveness period and 3
year transition phase?
• 5 year effectiveness period: because FDA still has 5 digit labeler codes available for
coming 10-15 years and this 5 year period will allow manufacturers to upgrade their
systems.
• 3 year transition phase: to allow manufacturers to use their existing packaging material
with 10 digit codes.
For e.g.: If a manufacturer has 1 year stock of packaging material and 2 years product shelf life.
Hence, in 3 years, all the products with 10 digits NDC code will be utilized in US market.

15. Thank you!