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N305767 N3 Ruling Active

The tariff classification of Diclofenac Sodium Gel 1% in dosage form, from India

Issued September 10, 2019 by U.S. Customs and Border Protection.

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N3 N305767 (September 10, 2019)

Tariff classification

HTS codes: 3004.90.9228

Headings: 3004

Product description

Diclofenac Sodium Gel 1%, imported in 100 grams, is a topical nonsteroidal anti-inflammatory drug (NSAID). It is indicated for the treatment of pain and inflammation associated with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and inflammation due to surgery or physical trauma.

CBP rationale

The applicable subheading for the Diclofenac Sodium Gel 1% in dosage form will be 3004.90.9228, 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 non-hormonal anti-inflammatory agents: Other.

Full text

N305767 September 10, 2019 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9228 Ms. Rhona M. Keeler NorthStar Healthcare 3300 Cork Airport Business Park Kinsale Road, Cork T12 XN72 Ireland RE: The tariff classification of Diclofenac Sodium Gel 1% in dosage form, from India Dear Ms. Keeler: In your letter dated August 13, 2019, you requested a tariff classification ruling. Diclofenac Sodium Gel 1%, imported in 100 grams, is a topical nonsteroidal anti-inflammatory drug (NSAID). It is indicated for the treatment of pain and inflammation associated with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and inflammation due to surgery or physical trauma. The applicable subheading for the Diclofenac Sodium Gel 1% in dosage form will be 3004.90.9228, 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 non-hormonal 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 the World Wide Web 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 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division

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