The tariff classification of BETAGAN® (levobunolol hydrochloride ophthalmic solution, USP) 0.5%, supplied in 10mL and 15mL plastic bottles with dropper tips and screw-down caps.
Issued November 1, 2004 by U.S. Customs and Border Protection.
Tariff classification
HTS codes: 3004.90.9185
Headings: 3004
Product description
The subject product, BETAGAN® (levobunolol hydrochloride ophthalmic solution, USP) 0.5%, is a sterile ophthalmic solution containing levobunolol hydrochloride (a noncardioselective beta-adrenoceptor blocking agent for ophthalmic use) as the active ingredient. BETAGAN® is indicated for use in the treatment of patients with chronic open-angle glaucoma or ocular hypertension. The solution is supplied in 10mL and 15mL plastic bottles with dropper tips and screw-down caps.
CBP rationale
The applicable subheading for BETAGAN® (levobunolol hydrochloride ophthalmic solution, USP) 0.5%, imported put up in 10mL and 15mL plastic bottles with dropper tips and screw-down caps, will be 3004.90.9185, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the eyes, ears or respiratory system: Other: Other.
Full text
NY L80563 November 1, 2004 CLA-2-30:RR:NC:2:238 L80563 CATEGORY: Classification TARIFF NO.: 3004.90.9185 Ms. Iliana G. Fuller Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 RE: The tariff classification of BETAGAN® (levobunolol hydrochloride ophthalmic solution, USP) 0.5%, supplied in 10mL and 15mL plastic bottles with dropper tips and screw-down caps. Dear Ms. Fuller: In your letter dated October 21, 2004, you requested a tariff classification ruling. The subject product, BETAGAN® (levobunolol hydrochloride ophthalmic solution, USP) 0.5%, is a sterile ophthalmic solution containing levobunolol hydrochloride (a noncardioselective beta-adrenoceptor blocking agent for ophthalmic use) as the active ingredient. BETAGAN® is indicated for use in the treatment of patients with chronic open-angle glaucoma or ocular hypertension. The solution is supplied in 10mL and 15mL plastic bottles with dropper tips and screw-down caps. The applicable subheading for BETAGAN® (levobunolol hydrochloride ophthalmic solution, USP) 0.5%, imported put up in 10mL and 15mL plastic bottles with dropper tips and screw-down caps, will be 3004.90.9185, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the eyes, ears or respiratory system: Other: 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 1-888-443-6332. 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, National Commodity Specialist Division
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