N242521 N2 Ruling Active

The tariff classification of Buspirone Hydrochloride Tablets, Pramipexole Dihydrochloride Extended Release Tablets, Minocycline Hydrochloride Extended Release Tablets, imported in dosage form, from India

Issued June 21, 2013 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 3004.20.0060, 3004.90.9140, 3004.90.9135

Headings: 3004

Product description

The first product, Buspirone Hydrochloride Tablets in 5 mg, 10 mg, 15 mg, and 30 mg, is a medicinal preparation containing Buspirone, an anxiolytic psychoactive drug, as an active ingredient. It is indicated for the management of anxiety disorders or in the short-term treatment of symptoms of anxiety. The second product, Pramipexole Dihydrochloride Extended Release Tablets in 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg, is a medicinal preparation containing Pramipexole, a dopamine agonist, as an active ingredient. It is indicated for the treatment of Parkinson’s disease. The third product, Minocycline Hydrochloride Extended Release Tablets in 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg, is a medicinal preparation containing Minocycline, a semisynthetic derivative of tetracycline, as an active ingredient. It is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.

CBP rationale

The applicable subheading for the Buspirone Hydrochloride Tablets imported in dosage form will be 3004.90.9135, 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 applicable subheading for the Pramipexole Dihydrochloride Extended Release Tablets imported in dosage form will be 3004.90.9140, 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: Other. The applicable subheading for the Minocycline Hydrochloride Tablets imported in dosage form will be 3004.20.0060, 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: Containing other antibiotics: Other: Other.

Full text

N242521 June 21, 2013 CLA-2-30:OT:RR:E:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9135; 3004.90.9140; 3004.20.0060 Mr. Pradeep Shah Zydus Pharmaceuticals (USA) Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Buspirone Hydrochloride Tablets, Pramipexole Dihydrochloride Extended Release Tablets, Minocycline Hydrochloride Extended Release Tablets, imported in dosage form, from India Dear Mr. Shah: In your letter dated May 21, 2013, you requested a tariff classification ruling. The first product, Buspirone Hydrochloride Tablets in 5 mg, 10 mg, 15 mg, and 30 mg, is a medicinal preparation containing Buspirone, an anxiolytic psychoactive drug, as an active ingredient. It is indicated for the management of anxiety disorders or in the short-term treatment of symptoms of anxiety. The second product, Pramipexole Dihydrochloride Extended Release Tablets in 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg, is a medicinal preparation containing Pramipexole, a dopamine agonist, as an active ingredient. It is indicated for the treatment of Parkinson’s disease. The third product, Minocycline Hydrochloride Extended Release Tablets in 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg, is a medicinal preparation containing Minocycline, a semisynthetic derivative of tetracycline, as an active ingredient. It is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris. The applicable subheading for the Buspirone Hydrochloride Tablets imported in dosage form will be 3004.90.9135, 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. The applicable subheading for the Pramipexole Dihydrochloride Extended Release Tablets imported in dosage form will be 3004.90.9140, 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: Other.” The rate of duty will be free. The applicable subheading for the Minocycline Hydrochloride Tablets imported in dosage form will be 3004.20.0060, 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: Containing other antibiotics: Other: Other.” 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 http://www.usitc.gov/tata/hts/. 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). 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 (646) 733-3033. Sincerely, Thomas J. Russo Director National Commodity Specialist Division

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