CLA-2-30:OT:RR:NC:N2:238
Ms. Marth M. Scott
NorthStar Healthcare
3300 Cork Airport Business Park
Kinsale Road
Cork, T12 XN72, Ireland
RE: The tariff classification of Lamotrigine IR tablets in dosage form, from India
Dear Ms. Scott:
In your letter dated December 12, 2016, you requested a tariff classification ruling.
The subject product, Lamotrigine IR tablets, is a medicinal preparation containing, Lamotrigine, an anticonvulsant drug, as the active ingredient. It is indicated for conversion to monotherapy in adults (16 years and greater) with partial seizures who are receiving treatment from other therapeutic agents and maintenance treatment of Bipolar I Disorder. It is also indicated as adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients 2 years old and greater. Lamotrigine IR tablets will be imported in retail packages in dosages of 25 mg, 100 mg, 150 mg and 200 mg.
The applicable subheading for the Lamotrigine IR tablets in dosage form will be 3004.90.9230, 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 (including those in the form of transdermal administration systems) 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 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