The tariff classification of Ketorolac Tromethamine Tablets, Levothyroxine Sodium Tablets, and Roflumilast Tablets in dosage form, from India

N325297 May 5, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.39.0050; 3004.90.9228; 3004.90.9285 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Ketorolac Tromethamine Tablets, Levothyroxine Sodium Tablets, and Roflumilast Tablets in dosage form, from India Dear Mr. Shah: In your letter dated April 7, 2022, you requested a tariff classification ruling. Ketorolac Tromethamine, imported in 10 mg tablets, is a nonsteroidal anti-inflammatory drug (NSAID). It is indicated for the short-term (5 days or less) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Levothyroxine Sodium is a synthetic version of thyroxine (thyroid hormone). It is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Levothyroxine Sodium will be imported in tablet form in dosages of 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Roflumilast, imported in 250 mcg and 500 mcg tablets, is a selective phosphodiesterase 4 (PDE4) inhibitor. It is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations. The applicable subheading for the Ketorolac Tromethamine Tablets in dosage form will be 3004.90.9228, 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 central nervous system: Analgesics, antipyretics and non-hormonal anti-inflammatory agents: Other.” The rate of duty will be free. The applicable subheading for the Levothyroxine Sodium Tablet in dosage form will be 3004.39.0050, 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, containing hormones or other products of heading 2937: Other: Other.” The rate of duty will be free. The applicable subheading for the Roflumilast Tablets in dosage form will be 3004.90.9285, 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. 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