CLA-2-30:OT:RR:NC:N2:238
Mr. Pradeep Shah
Zydus Pharmaceuticals USA Inc.
73 Route 31 North
Pennington, NJ 08534
RE: The tariff classification of Ethacrynate Sodium Injection and Mycophenolate Mofetil Injection in dosage form, from India
Dear Mr. Shah:
In your letter dated August 1, 2017, you requested a tariff classification ruling.
The first product, Ethacrynate Sodium for Injection, imported in 50 mg is a diuretic used in the treatment of edema.
The second product, Mycophenolate Mofetil for Injection, imported in 500 mg is an immunosuppressant. It is indicated for the prevention of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
The applicable subheading for Ethacrynate Sodium Injection in dosage form will be 3004.90.9265, 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 the forms of packings for retail use: Other: Other: Other: Preparations primarily affecting the electrolytic, caloric or water balance: Diuretics.” The rate of duty will be free.
The applicable subheading for Mycophenolate Mofetil Injection in dosage form will be 3004.90.9215, 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: Antineoplastic and immunosuppressive medicaments." 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).
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