N141037 N1 Ruling Active

The tariff classification of Tramadol Hydrochloride Tablets and Tramadol Hydrochloride and Acetaminophen Tablets in dosage form, from India

Issued January 21, 2011 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 3004.90.9128

Headings: 3004

Product description

The first product, Tramadol Hydrochloride tablets in 50 mg dosage form, is a medicinal preparation containing Tramadol, a centrally acting analgesic, as the active ingredient. It is indicated for the management of moderate to moderately severe pain in adults. The second product, Tramadol Hydrochloride and Acetaminophen tablets in 37.5 mg/325 mg dosage form, is a medicinal preparation containing Tramadol Hydrochloride and Acetaminophen, as the active ingredients. The combination of these two drugs is indicated for the short term relief of moderately severe acute pain in adults.

CBP rationale

The applicable subheading for the Tramadol Hydrochloride Tablets in 50 mg and Tramadol Hydrochloride and Acetaminophen Tablets in 37.5mg/325 mg will be 3004.90.9128, 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: Analgesics, antipyretics and nonhormonal anti-inflammatory agents: Other.

Full text

N141037 January 21, 2011 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9128 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Tramadol Hydrochloride Tablets and Tramadol Hydrochloride and Acetaminophen Tablets in dosage form, from India Dear Mr. Shah: In your letter dated December 20, 2010, you requested a tariff classification ruling. The first product, Tramadol Hydrochloride tablets in 50 mg dosage form, is a medicinal preparation containing Tramadol, a centrally acting analgesic, as the active ingredient. It is indicated for the management of moderate to moderately severe pain in adults. The second product, Tramadol Hydrochloride and Acetaminophen tablets in 37.5 mg/325 mg dosage form, is a medicinal preparation containing Tramadol Hydrochloride and Acetaminophen, as the active ingredients. The combination of these two drugs is indicated for the short term relief of moderately severe acute pain in adults. The applicable subheading for the Tramadol Hydrochloride Tablets in 50 mg and Tramadol Hydrochloride and Acetaminophen Tablets in 37.5mg/325 mg will be 3004.90.9128, 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: Analgesics, antipyretics and nonhormonal anti-inflammatory agents: 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 Harvey Kuperstein at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division

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