CLA-2-30:OT:RR:NC:N3:138
Ms. Paulina Radaczynska
BluePoint Laboratories
Eastgate Business Park
8 Eastgate Avenue
Little Island, Cork
Ireland
RE: The tariff classification of Potassium Chloride Extended-Release Capsules, Famotidine Tablets, Fluoxetine Capsules, and Levetiracetam Tablets in dosage form, from India
Dear Ms. Radaczynska:
In your letter dated May 29, 2019, you requested a tariff classification ruling.
Potassium Chloride, imported in 750 mg extended-release capsules, is a medicinal preparation containing Potassium Chloride, as the active ingredient. It is indicated for the treatment of hypokalemia with or without metabolic alkalosis, indigitalis intoxications, and in patients with hypokalemic familial periodic paralysis.
Famotidine, imported in 20 mg and 40 mg tablets, is a medicinal preparation containing Famotidine, a histamine H2 receptor antagonist, as the active ingredient. It is indicated for the treatment of active duodenal ulcer (DU), active gastric ulcer (GU), symptomatic nonerosive gastroesophageal reflux disease (GERD) and erosive esophagitis due to GERD.
Fluoxetine, imported in 10 mg, 20 mg and 40 mg capsules, is a medicinal preparation containing Fluoxetine Hydrochloride, an antidepressant, as the active ingredient. It is indicated for the acute and maintenance treatment of major depressive disorder, obsessions and compulsions in patients with obsessive compulsive disorder, binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa, and panic disorder with or without agoraphobia.
Levetiracetam, imported in 250 mg, 500 mg, 750 and 1000 mg tablets, is a medicinal preparation containing Levetiracetam, an anticonvulsant, as the active ingredient. It is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
The applicable subheading for Potassium Chloride Extended-Release Capsules in dosage form will be 3004.90.9270, 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: Preparations primarily affecting the electrolytic, caloric or water balance: Other.” The rate of duty will be free.
The applicable subheading for 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 Fluoxetine Capsules 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.
The applicable subheading for Levetiracetam Tablets in dosage form will be 3004.90.9230, 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: Anticonvulsants, hypnotics and sedatives.” 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