The tariff classification of Isotretinoin Capsules, Ivermectin Tablets and Venlafaxine Extended-Release Tablets in dosage form, from India

N325050 April 22, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9214; 3004.90.9235; 3004,90.9245 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Isotretinoin Capsules, Ivermectin Tablets and Venlafaxine Extended-Release Tablets in dosage form, from India Dear Mr. Shah: In your letter dated March 25, 2022, you requested a tariff classification ruling. Isotretinoin, imported in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg capsules, is a synthetic Vitamin A acid derivative known as 13-cis-retinoic acid. Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Ivermectin, imported in 3 mg tablets, is a semisynthetic, anthelmintic agent for oral ministration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents. It is indicated for the treatment of Strongyloidiasis of the intestinal tract and Onchocerciasis, two conditions caused by parasitic worms. Venlafaxine, imported in 37.5 mg, 75 mg, 150 mg and 225 mg extended release tablets, is an antidepressant. It is indicated for the management of major depressive disorder (MDD), generalized anxiety disorder (GAD), social anxiety disorder (social phobia) and panic disorder. The applicable subheading for the Isotretinoin Capsules in dosage form will be 3004.90.9245, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Dermatological agents and local anesthetics.” The rate of duty will be free. The applicable subheading for the Ivermectin Tablets in dosage form will be 3004.90.9214, HTSUS, which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Anti-infective medicaments: Other.” The rate of duty will be free. The applicable subheading for the Venlafaxine Extended-Release Tablets in dosage form will be 3004.90.9235, HTSUS, which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents.” The rate of duty will be free. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at https://hts.usitc.gov/current. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Judy Lee at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division