CLA-2-30:OT:RR:NC:N1:138
Mr. Pradeep Shah
Zydus Pharmaceuticals USA, Inc.
73 Route 31 North
Pennington, NJ 08810
RE: The tariff classification of Azithromycin Oral Suspension and Clomipramine Hydrochloride Capsules in dosage form, from India
Dear Mr. Shah:
In your letter dated June 18, 2018, you requested a tariff classification ruling.
Azithromycin is described in literature as a semisynthetic derivative of Erythromycin, a naturally occurring macrolide antibiotic. It is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms. Azithromycin will be imported in dosages of 300 mg, 600 mg, 900 mg and 1200 mg oral suspensions. According to Headquarters Ruling Letter H128140, dated November 7, 2011, Azithromycin is not regarded as an erythromycin derivative for tariff classification purposes.
Clomipramine Hydrochloride is a tricyclic antidepressant drug indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). It will be imported in dosages of 25 mg, 50 mg and 75 mg capsules.
The applicable subheading for Azithromycin Oral Suspension in dosage form will be 3004.20.0060, 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, containing antibiotics: Other: Other.” The rate of duty will be free.
The applicable subheading for Clomipramine Hydrochloride 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.
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