CLA-2-30:OT:RR:NC:N3:138
Pradeep Shah
Zydus Pharmaceuticals USA, Inc.
73 Route 31 North
Pennington, NJ 08534
RE: The tariff classification of Gadobutrol Injection in dosage form, from China
Dear Mr. Shah:
In your letter dated May 20, 2025, you requested a tariff classification ruling.
Gadobutrol, imported in 604.72 mg, 7.5 mL, 10 mL and 15 mL, is a gadolinium-based contrast agent
(GBCA). It is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients,
including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal
vascularity of the central nervous system. It is also indicated for use with MRI in adult patients to assess the
presence and extent of malignant breast disease, magnetic resonance angiography (MRA) and cardiac MRI.
The applicable subheading for the Gadobutrol Injection in dosage form will be 3006.30.5000, Harmonized
Tariff Schedule of the United States (HTSUS), which provides for “Pharmaceutical goods specified in note 4
to this chapter: Opacifying preparations for X-ray examinations; diagnostic reagents designed to be
administered to the patient: Other.” The general rate of duty will be free.
Effective March 4, 2025, pursuant to U.S. Note 2(u) to Subchapter III, Chapter 99, all products of China and
Hong Kong as provided by heading 9903.01.24, HTSUS, other than products classifiable under headings
9903.01.21, 9903.01.22, and 9903.01.23, HTSUS, will be subject to an additional 20 percent ad valorem rate
of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.24, in addition
to subheading 3006.30.5000, HTSUS, listed above.
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 from all countries
will be subject to an additional 10 percent ad valorem rate of duty. Your product falls with 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 3006.30.5000, 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)
Steven A. Mack
Director
National Commodity Specialist Division