CLA-2-30:OT:RR:NC:N1:138
Ms. Paulina Radaczynska
BluePoint Laboratories
Eastgate Business Park 8 Eastgate Avenue
Little Island T45 NF24
Ireland
RE: The tariff classification of Montelukast Sodium Tablets in dosage form, from India
Dear Ms. Radaczynska:
In your letter dated August 9, 2018, you requested a tariff classification ruling.
Montelukast Sodium imported in 10 mg tablet form, is a medicinal preparation containing Montelukast Sodium, a leukotriene receptor antagonist (LTRA), as the active ingredient. It is indicated for the treatment of asthma and the relief of symptoms of seasonal allergies in patients 15 years of age and older.
The applicable subheading for the Montelukast Sodium Tablets in dosage form will be 3004.90.9285, 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 (…) 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