FAQ

=FAQ -= DUNS Number FAQ Establishment Registration FAQ

Subject/Keywords
API, Route of Administration, Drug Listing

Question
What do I enter for Route of Administration when listing API?

Answer
For API, enter Route of Administration as NOT APPLICABLE

Subject/Keywords
NDC Code, Setid, Drug Listing

Question
If Company A has listed NDC 1111-11-11111, do I need to list it as well? **[need example here]**

Answer
No. Each NDC code must be associated with only 1 setid.

Subject/Keywords
Drug Listing, Changes-Being-Effected, CBE

Question
What happens if I list a change to labeling before I submit the CBE to the Review Division?

Answer
The change to labeling will be posted to Daily Med. The CBE will go to the Review Division for review.

Subject/Keywords
Drug Listing, Changes-Being-Effected, CBE

Question
What happens if I submit the CBE to the Review Division and do not list the change to labeling via ELIST?

Answer
The CBE will go to the Review Division for review. However, the change to labeling will NOT be posted to Daily Med.