The tariff classification of Carbidopa/Levodopa Tablets, Dexamethasone Tablets and Leuprolide Acetate Injection in dosage form, from India

N325106 April 27, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9240; 3004.32.0000; 3004.39.0050 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Carbidopa/Levodopa Tablets, Dexamethasone Tablets and Leuprolide Acetate Injection in dosage form, from India Dear Mr. Shah: In your letter dated March 29, 2022, you requested a tariff classification ruling. Carbidopa/Levodopa, imported in 10 mg/100 mg, 25 mg/100 mg and 25 mg/250 mg tablets, is a combination medication containing Carbidopa and Levodopa as the active ingredients. Carbidopa/Levodopa is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Dexamethasone, imported in 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg, and 6 mg tablets, is in a class of steroidal drugs known as corticosteroid, specifically glucocorticosteroid. It decreases your body's natural defensive response and reduces symptoms such as swelling and allergic-type reactions. Dexamethasone is indicated for the control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Leuprolide Acetate Injection, imported in 2.8 mL, is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone. It is indicated for the palliative treatment of advanced prostatic cancer. The applicable subheading for Carbidopa/Levodopa Tablets in dosage form will be 3004.90.9240, 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: Other.” The rate of duty will be free. The applicable subheading for the Dexamethasone Tablets in dosage form will be 3004.32.0000, 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: Containing corticosteroid hormones, their derivatives or structural analogues.” The rate of duty will be free. The applicable subheading for the Leuprolide Acetate Injection 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. 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