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N333935 N3 Ruling Active

The tariff classification of Balsalazide Disodium Capsules USP and Carbidopa Tablets in dosage form, from Taiwan and India, respectively

Issued July 28, 2023 by U.S. Customs and Border Protection.

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N3 N333935 (July 28, 2023)

Tariff classification

HTS codes: 3004.90.9240, 3004.90.9260

Headings: 3004

Product description

Balsalazide Disodium, imported in 750 mg capsules, is an anti-inflammatory drug that is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. In your letter,

CBP rationale

The applicable subheading for the Balsalazide Disodium Capsules in dosage form will be 3004.90.9260, 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 digestive system: Other. The applicable subheading for the Carbidopa Tablets in dosage form will be 3004.90.9240, 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.

Full text

N333935 July 28, 2023 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9240; 3004.90.9260 Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 N Pennington, NJ 08534 RE:  The tariff classification of Balsalazide Disodium Capsules USP and Carbidopa Tablets in dosage form, from Taiwan and India, respectively Dear Mr. Shah: In your letter dated July 11, 2023, you requested a tariff classification ruling. Balsalazide Disodium, imported in 750 mg capsules, is an anti-inflammatory drug that is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.  In your letter, you stated Balsalazide Disodium capsules will be imported from India. Carbidopa, imported in 25 mg tablets, is in a class of medications called decarboxylase inhibitors.  It is indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. The applicable subheading for the Balsalazide Disodium Capsules in dosage form will be 3004.90.9260, 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 digestive system: Other.”  The rate of duty will be free. The applicable subheading for the Carbidopa Tablets in dosage form will be 3004.90.9240, 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. 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 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 and Border Protection 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, please contact National Import Specialist Judy Lee at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division

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