N356511

N356511December 19, 2025CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9215 Ciara HorganNorthStar Healthcare UC3300 Kinsale RoadCork Airport Business ParkCork, T12XN72IrelandRE: The tariff classification of Mycophenolate Mofetil Oral Suspension in dosage form, from IndiaDear Ms. Horgan:In your letter dated November 27, 2025 , you requested a tariff classification ruling.Mycophenolate Mofetil Oral Suspension, imported in 200 mg/mL, is an immunosuppressant. It is indicatedfor the prevention of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.The applicable subheading for the Mycophenolate Mofetil Oral Suspension in dosage form will be3004.90.9215, 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: Antineoplastic and immunosuppressivemedicaments.” The general rate of duty will be free.The duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenienceand are subject to change. The text of the most recent HTSUS and the accompanying duty rates are providedat https://hts.usitc.gov/.This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or othercharges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and otherduties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to theclassification stated above, the merchandise covered by this ruling may also need to be reported with eitherthe Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisionscovering exceptions to such tariffs. For further information to assist with the importation process, please refer to the frequently updated CargoSystems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and Frequently Asked Questions onthe Trade Remedy/IEEPA page at https://www.cbp.gov/trade/programs-administration/trade-remedies/IEEPA-FAQ.This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public HealthSecurity and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which areadministered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, andCosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or byvisiting their website at www.fda.gov.The holding set forth above applies only to the specific factual situation and merchandise description asidentified 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 theinformation furnished in the ruling letter, whether directly, by reference, or by implication, is accurate andcomplete in every material respect. In the event that the facts are modified in any way, or if the goods do notconform to these facts at time of importation, you should bring this to the attention of U.S. Customs andBorder 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 periodicverification by CBP.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, (for)Evan ConceicaoDesignated Official Performing the Duties of the Division DirectorNational Commodity Specialist Division

set forth above applies only to the specific factual situation and merchandise description asidentified 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 theinformation furnished in the ruling letter, whether directly, by reference, or by implication, is accurate andcomplete in every material respect. In the event that the facts are modified in any way, or if the goods do notconform to these facts at time of importation, you should bring this to the attention of U.S. Customs andBorder 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 periodicverification by CBP.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Judy Lee at judy.h.lee@cbp.dhs.gov.
Sincerely,
(for)Evan ConceicaoDesignated Official Performing the Duties of the Division DirectorNational Commodity Specialist Division