Per FDA requirements, the manufacturer is responsible for all drug listings, including listings done for private label distributors (PLDs) using the PLD’s National Drug Code (NDC) labeler. The actual listings may be done by, private label distributors, US agents for the manufacturers, and importers of the manufacturers, regulatory consultants, and drug sponsors acting on behalf of the manufacturers or distributors. Placing the requirement on the manufacturers means that if a listing is not done it is the manufacturer that is responsible, even if it is a listing for a private label distributor. See 21CFR207.41, (c)(1) and (c)(2), at this page; (c)(1) is for distributor listing, (c)(2) for manufacturer listing.