Animal drugs
(iii) Animal drugs. (A) For each animal drug that is subject to section 512 of the Federal Food, Drug, and Cosmetic Act, which includes, but is not limited to, new animal drugs that have been approved, conditionally approved, or indexed under sections 512, 571, or 572 of the Federal Food, Drug, and Cosmetic Act, a copy of all current labeling (except that only one representative container or carton label need be submitted where differences exist only in the quantity of contents statement), including the content of labeling as defined in 207.1; (B) For all other animal drugs, a copy of the current label (except that only one representative container or carton label need be submitted where differences exist only in the quantity of contents statement), the package insert, the content of labeling as defined in 207.1, and a representative sampling of any other labeling; (iv) All other listed drugs. For all other listed drugs, including unfinished drugs, the label (if any), except that only one representative label need be submitted where differences exist only in the quantity of contents statement. (16) Listing submissions described in 207.41(c)(2) for human drugs manufactured for private label distribution must include all information specified in 207.49(a)(2) through (14) and: (i) The appropriate NDC(s) (as described in 207.33) that include the private label distributor's labeler code and all package code variations; (ii) The name, mailing address, telephone number, and email address of the private label distributor; and (iii) For drugs bearing the NDC(s) reported under paragraph (a)(16)(i) of this section, labeling as described in paragraph (a)(15) of this section that accompanies the private label distributor's product.