The tariff classification of Ferric Citrate Tablets and Bosentan Tablets for Oral Suspension in dosage form from India

N351520
August 18, 2025
CLA-2-30:OT:RR:NC:N3:138
CATEGORY: Classification
TARIFF NO.: 3004.90.9221; 3004.90.9270; 9903.01.32
Pradeep Shah Zydus Pharmaceuticals USA inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Ferric Citrate Tablets and Bosentan Tablets for Oral Suspension in dosage form from India Dear Mr. Shah: In your letter dated July 21, 2025, you requested a tariff classification ruling. Ferric Citrate, imported in 210 mg tablets, is in a class of medications called phosphate binders. It is indicated for the treatment of hyperphosphatemia (elevated level of phosphate in the blood) in patients with chronic kidney disease (CKD) who are on dialysis. Ferric Citrate is also used to treat iron deficiency anemia in patients with CKD who are not on dialysis. Bosentan for oral suspension, imported in 32 mg tablets, is a dual endothelin receptor antagonist. It is indicated for the treatment of pulmonary arterial hypertension (PAH) in adults to improve exercise ability and decrease clinical worsening, and in pediatric patients (3 years and older) with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability. The applicable subheading for the Ferric Citrate Tablets in dosage form will be 3004.90.9270, 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: Preparations primarily affecting the electrolytic, caloric or water balance: Other.” The general rate of duty will be free. The applicable subheading for the Bosentan Tablets for Oral Suspension in dosage form will be 3004.90.9221, 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: Cardiovascular medicaments: Other.”

Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time, products of India will be subject to an additional ad valorem rate of duty of 25 percent. Your product falls within an excepted subheading. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.32, in addition to subheadings 3004.90.9221 and 3004.90.9270, HTSUS, listed above. The tariffs and additional duties cited above are current as of this ruling’s issuance. 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/. 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. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. 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,
(for) James Forkan Acting Director National Commodity Specialist Division