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

Rosie Hipwell
Bluepoint Laboratories Eastgate Business Park 8 Eastgate Avenue Little Island, T45 NF24 Ireland

RE: The tariff classification of Duloxetine Hydrochloride Delayed-Release Capsules in dosage form, from India

Dear Ms. Hipwell:

In your letter dated May 9, 2023, you requested a tariff classification ruling.

Duloxetine Hydrochloride, imported in 20 mg, 30 mg and 60 mg delayed-release capsules, is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI).  It is indicated for the treatment of major depressive disorder (MDD), generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain.  

The applicable subheading for the Duloxetine Hydrochloride Delayed-Release Capsules in dosage form will be 3004.90.9235, 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: 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 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 and Border Protection 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, please contact National Import Specialist Judy Lee at [email protected].

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division