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.