CLA-2-30:OT:RR:NC:N3:138
Andrew O’ Brien
NorthStar Healthcare UC
3300 Cork Airport Business Park
Cork T12 XN72
RE: The tariff classification of Azelastine Hydrochloride (HCL) Nasal Spray in dosage form, from Italy
Dear Mr. O’ Brien:
In your letter dated April 14, 2025, you requested a tariff classification ruling.
Azelastine Hydrochloride Nasal Spray, imported in 30 mL, is an antihistamine. It is indicated for the
treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years of age and
older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years
of age and older.
The applicable subheading for the Azelastine Hydrochloride (HCL) Nasal Spray in dosage form will be
3004.90.9280, 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 eyes, ears
or respiratory system: Other: Antihistamines.” The rate of duty will be free.
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. Products of China, including Hong Kong
and Macau, will be assessed an additional ad valorem rate of duty of 125 percent. Products from all other
countries will be subject to an additional 10 percent ad valorem rate of duty. 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 subheading 3004.90.9280, HTSUS, listed above.
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,
Steven A. Mack
Director
National Commodity Specialist Division