CLA-2-30:OT:RR:NC:N3:138
Trish O’ Mahoney
Northstar Healthcare Ltd
3300 Cork Airport Business Park, Kinsale Road
Cork T12XN72
Ireland
RE: The tariff classification of Pregabalin CV Capsules in dosage form, from India
Dear Ms. O’ Mahoney:
In your letter dated September 16, 2025, you requested a tariff classification ruling.
Pregabalin CV, imported in 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg and 300 mg capsules, is an
anticonvulsant and belongs to the drug class of gabapentinoids. It is indicated for the management of
neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, treatment of partial
onset seizures, fibromyalgia and management of neuropathic pain associated with spinal cord injury.
The applicable subheading for the Pregabalin CV Capsules in dosage form will be 3004.90.9236,
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:
Anticonvulsants, hypnotics and sedatives.” The general rate of duty will be free.
Effective August 27, 2025, Executive Order 14339 imposed additional duties on products from India. At this
time, products of India provided by heading 9903.01.84, except for products described in headings
9903.01.85 – 9903.01.89, 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. 9903.01.86, in addition to subheading 3004.90.9236, 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 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 subheading 3004.90.9236, 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.
Pregabalin CV Capsules may also be subject to the Controlled Substances Act, which is administered by the
U.S. Drug Enforcement Administration (DEA), Office of Diversion Control. Information on the Controlled
Substances Act can be obtained by contacting the DEA at (800) 882-9539, or by visiting their website at
www.dea.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)
Evan Conceicao
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division