SPL Set ID: ed7b5d41-7475-4c10-99b9-b62b3434ae60

JATENZO (testosterone undecanoate) for oral use is provided as a gelatin capsule containing testosterone undecanoate, a fatty-acid ester of testosterone. Testosterone undecanoate is a white to off-white yellow crystalline powder. Testosterone, an androgen, is formed by cleavage of the ester side chain of testosterone undecanoate. Testosterone undecanoate is chemically described as 17β-hydroxyandrost-4-en-3-one undecanoate. It has the empirical formula of C 30 H 48 O 3 and the molecular weight of 456.7. The structural formula for testosterone undecanoate is presented in Figure 1. Figure 1: Testosterone Undecanoate JATENZO capsules are available in three strengths of 158 mg, 198 mg, and 237 mg. The 158 mg strength is an opaque red capsule that contains 158 mg of testosterone undecanoate and is imprinted with “158” in white ink. The 198 mg strength is an opaque white capsule that contains 198 mg of testosterone undecanoate and is imprinted with “198” in red ink. The 237 mg strength is an opaque orange capsule that contains 237 mg of testosterone undecanoate and is imprinted with “237” in white ink. All capsule strengths also contain oleic acid, polyoxyl 40 hydrogenated castor oil (Cremophor RH 40), borage seed oil, peppermint oil, and butylated hydroxytoluene as inactive ingredients. Gelatin capsule shells are composed of the following inactive ingredients: Gelatin, sorbitol, glycerin, and purified water in all strengths, iron oxide red in 158 mg, FD&C Yellow #6 in 158 and 237 mg, and titanium dioxide in 198 and 237 mg capsules. Figure 1