The tariff classification of Albuterol Tablets and Azelastine Hydrochloride Nasal Spray in dosage form, from India

N309801 March 13, 2020 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9280; 3004.90.9285 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Albuterol Tablets and Azelastine Hydrochloride Nasal Spray in dosage form, from India Dear Mr. Shah: In your letter dated February 13, 2020, you requested a tariff classification ruling. Albuterol, imported in 2 mg and 4 mg tablets, is a bronchodilator. It is indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive disease. Azelastine Hydrochloride Nasal Spray, imported in 137 mg, is an antihistamine. It is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years of age and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years of age and older. The applicable subheading for the Albuterol Tablets in dosage form will be 3004.90.9285, 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: Medicaments primarily affecting the eyes, ears or respiratory system: Other: Other.” The rate of duty will be free. The applicable subheading for the Azelastine Hydrochloride Nasal Spray in dosage form will be 3004.90.9280, 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: Medicaments primarily affecting the eyes, ears or respiratory system: Other: Antihistamines.” 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