(a) Specifications. Each milliliter of solution contains:

(1) 180 milligrams (mg) tildipirosin.

(2) [Reserved]

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.733 of this chapter.

(d) Conditions of use—(1) Cattle—(i) Amount. Administer 4 mg/kg of bodyweight one time by subcutaneous injection in the neck.

(ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle; and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni.

(iii) Limitations. Cattle intended for human consumption must not be slaughtered within 21 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]