J86654 J8 Ruling Active

The tariff classification of ZYMAR™ (gatifloxacin ophthalmic solution) 0.3%

Issued July 8, 2003 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 3004.90.9110

Headings: 3004

Product description

The subject product, ZYMAR™ (gatifloxacin ophthalmic solution) 0.3%, is an ophthalmic medicament containing gatifloxacin (one of the fluoroquinolone-class of synthetic antibacterial agents) as the active ingredient. According to the package insert, ZYMAR™ is indicated for the treatment of bacterial conjunctivitis, and is supplied, sterile, in 6mL and 8mL plastic bottles with controlled dropper tips. .

CBP rationale

The applicable subheading for the subject product will be 3004.90.9110, 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: Anti-infective medicaments: Other.

Full text

NY J86654 July 8, 2003 CLA-2-30:RR:NC:2:238 J86654 CATEGORY: Classification TARIFF NO.: 3004.90.9110 Ms. Iliana G. Fuller Allergan, Inc. 2525 Drive P.O. Box 19534 Irvine, CA 92623-9534 RE: The tariff classification of ZYMAR™ (gatifloxacin ophthalmic solution) 0.3% Dear Ms. Fuller: In your letter dated June 30, 2003, you requested a tariff classification ruling. The subject product, ZYMAR™ (gatifloxacin ophthalmic solution) 0.3%, is an ophthalmic medicament containing gatifloxacin (one of the fluoroquinolone-class of synthetic antibacterial agents) as the active ingredient. According to the package insert, ZYMAR™ is indicated for the treatment of bacterial conjunctivitis, and is supplied, sterile, in 6mL and 8mL plastic bottles with controlled dropper tips. . The applicable subheading for the subject product will be 3004.90.9110, 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: Anti-infective medicaments: Other.” The rate of duty will be free. This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544. 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, National Commodity Specialist Division

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