The tariff classification and country of origin of Naltrexone Hydrochloride Tablets in dosage form

N361037May 18, 2026CLA-2-30:OT:RR:NC:N3:138
CATEGORY: Classification; Origin
TARIFF NO.: 3004.49.0070
Pradeep ShahZydus Pharmaceuticals USA Inc.73 Route 31 NorthPennington, NJ 08534RE: The tariff classification and country of origin of Naltrexone Tablets in dosage formHydrochlorideDear Mr. Shah:In your letter dated
April 27, 2026
, you requested a tariff classification and country of origin determinationruling.Naltrexone Hydrochloride, imported in 50 mg tablets, is an opiate alkaloid derivative. It is an opioidantagonist indicated for the treatment of alcohol dependence and for the blockade of the effects ofexogenously administered opioids.The applicable subheading for the Naltrexone Hydrochloride Tablets in dosage form will be 3004.49.0070,Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … consistingof mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in formsor packings for retail sale: Other, containing alkaloids or derivatives thereof: Other: Other: Other.” Thegeneral rate of duty will be free.The 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 providedat https://hts.usitc.gov/.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.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 other
duties as provided for in Subchapter III to Chapter 99, HTSUS.Thus, for example, in addition to the classification 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 the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies.You also requested a country of origin determination. You stated that the active pharmaceutical ingredient(API), Naltrexone Hydrochloride is manufactured in Germany and that the finished tablets in dosage form aremade in India. In India, the Naltrexone Hydrochloride will be mixed with various inactive ingredients toproduce the final Naltrexone Hydrochloride Tablets in dosage form.When determining the country of origin, the substantial transformation analysis is applicable. See, e.g.,Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether asubstantial transformation will occur is whether an article emerges from a process with a new name,character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v.United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993).In this case, we find the mixing of the active ingredient Naltrexone Hydrochloride (made in Germany) withthe inactive ingredients into the final Naltrexone Hydrochloride Tablets in dosage form in India does notresult in a substantial transformation and the country of origin will be Germany.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 [email protected].
Sincerely,
(for)James P. ForkanDirectorNational Commodity Specialist Division