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NY R02462




August 31, 2005

CLA-2-30:RR:NC:238:R02462

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9120

Ms. Denise Demkowicz
Manager, Operations
GeneraMedix Inc.
150 Allen Road
Liberty Corner, NJ 07938

RE: The tariff classification of Amiodarone Hydrochloride Injection single dose vials for intravenous infusion from Ireland.

Dear Ms. Demkowicz:

In your letter dated August 22, 2005 you requested a tariff classification ruling.

The subject product, Amiodarone Hydrochloride Injection, is a formulation containing 5% by weight Amiodarone Hydrochloride. It is presented in three forms: 50mg/mL 3mL Single Dose Vial (10 pack); 50mg/mL 9mL Single Dose Vial (10 pack); 50mg/mL 18mL Single Dose Vial (one vial only). The vials are put up in paperboard boxes for retail sale. According to the official monograph, Amiodarone Hydrochloride is indicated for the initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia.

The applicable subheading for the three forms of Amiodarone Hydrochloride Injection will be 3004.90.9120, Harmonized Tariff Schedule of the United States (HTS), 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: Cardiovascular medicaments.” The rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which are administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-463-6332.  

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 Harvey Kuperstein at 646-733-3033.

Sincerely,

Robert B. Swierupski
Director,

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