§207.49. What listing information must a registrant submit for a drug it manufactures? — Inbound Citations

(2) For human prescription drugs that are not subject to section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act: The labeling equivalent to the content of the prescription drug labeling (as specified in §§ 201.56, 201.57, and 201.80 of this chapter), including all text, tables, and figures.

(d) ? (1) An NDC is proposed for assignment by FDA when it is submitted for the first time with listing information in accordance with § 207.49 or § 207.53, as applicable.

(b) Registrants must provide listing information for each drug in accordance with the listing requirements described in §§ 207.49, 207.53, and 207.54 that correspond to the activity or activities they engage in for that drug.

(i) Provide listing information, in accordance with §§ 207.49, 207.53, and 207.54, for any drug manufactured, repacked, relabeled, or salvaged by them for commercial distribution that has not been previously listed;

(2) After a drug is marketed, information obtained under § 207.33, § 207.49, § 207.53, § 207.54, or § 207.57.

(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.

(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.

(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.

(2) The names of any inactive ingredients submitted under § 207.49(a)(4) for which the registrant makes a valid assertion of confidentiality under § 20.61 of this chapter or other provision of law, or

(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.

(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.

(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.

(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.

(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.

(3) Drug listing information obtained under § 207.33(d)(3), § 207.49(a)(9) and (12), § 207.53(b) and (c), or § 207.54(a) or (c).

(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.

(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.

(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.

(3) Drug listing information obtained under § 207.33(d)(3), § 207.49(a)(9) and (12), § 207.53(b) and (c), or § 207.54(a) or (c).

(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.

(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.