CLA-2-30:OT:RR:NC:N3:138

Mr. Pradeep Shah
Zydus Pharmaceuticals USA Inc.
73 Route 31 North
Pennington, NJ 08534

RE: The tariff classification of Sevelamer Carbonate Tablets and Triazolam Tablets in dosage form, from India

Dear Mr. Shah:

In your letter dated May 1, 2019, you requested a tariff classification ruling.

Sevelamer Carbonate, imported in 800 mg tablets, is a phosphate binder that is available by prescription only. It is indicated for the control of serum phosphorus in patients with Chronic Kidney Disease (CDK) on hemodialysis.

Triazolam, imported in 0.125 mg and 0.25 mg tablets, is a triazolobenzodiazepine hypnotic agent. It is indicated for the short term treatment of insomnia.

The applicable subheading for the Sevelamer Carbonate Tablets 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 the Triazolam 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.

Triazolam may also be subject to the Controlled Substances Act, which is administered by the U.S. Drug Enforcement Administration (DEA), Office of Diversion Control. Information on the Controlled Substances Act can be obtained by contacting the DEA at (800) 882-9539, or by visiting their website at www.dea.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