The tariff classification of Fesoterodine Fumarate Extended-Release Tablets, Famotidine Tablets and Lenalidomide Capsules, in dosage form, from India

N324975 April 20, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9291; 3004.90.9260; 3004.90.9215 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Fesoterodine Fumarate Extended-Release Tablets, Famotidine Tablets and Lenalidomide Capsules, in dosage form, from India Dear Mr. Shah: In your letter dated March 23, 2022, you requested a tariff classification ruling. Fesoterodine Fumarate, imported in 4 mg and 8 mg extended-release tablets, is an antimuscarinic drug. It is indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. Famotidine, imported in 20 mg and 40 mg tablets, is a histamine H2 receptor antagonist. It is indicated for the treatment of active duodenal ulcer (DU), active gastric ulcer, symptomatic non-erosive gastroesophageal reflux disease (GERD), and erosive esophagitis due to GERD, diagnosed by biopsy. It is also indicated in adult patients for the treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasias) and reduction of the risk of DU recurrence. Lenalidomide, imported in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg capsules, is in a class of medications called immunomodulatory agents. It is used in combination with dexamethasone for the treatment of adult patients with multiple myeloma (MM). The applicable subheading for the Fesoterodine Fumarate Extended-Release Tablets will be 3004.90.9291, 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: Other.” The rate of duty will be free. The applicable subheading for the Famotidine Tablets in dosage form will be 3004.90.9260, 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 digestive system: Other.” The rate of duty will be free. The applicable subheading for the Lenalidomide Capsules in dosage form will be 3004.90.9215, 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: Antineoplastic and immunosuppressive medicaments.” 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