N361639 New York Ruling Active

The tariff classification of Nintedanib Capsules in dosage form, from India

Issued May 26, 2026 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 3004.90.9216

Headings: 3004

Product description

Nintedanib imported in 100 mgand 150 mg capsules, is in a class of medications called Tyrosine Kinase, Inhibitor (TKI)It is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF), and. chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

CBP rationale

The applicable subheading for the Nintedanib Capsules in dosage form will be 3004.90.9216, HarmonizedTariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed orunmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packingsfor retail sale: Other: Other: Other: Antineoplastic and immunosuppressive medicaments.

Full text

N361639May 26, 2026CLA-2-30:OT:RR:NC:N3:138
CATEGORY: Classification
TARIFF NO.: 3004.90.9216
Pradeep ShahZydus Pharmaceuticals USA Inc.73 Route 31 NorthPennington, NJ 08534RE: The tariff classification of Nintedanib Capsules in dosage form, from IndiaDear Mr. Shah:In your letter dated
May 19, 2026
, you requested a tariff classification ruling.Nintedanib imported in 100 mgand 150 mg capsules, is in a class of medications called Tyrosine Kinase, Inhibitor (TKI)It is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF), and. chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.The applicable subheading for the Nintedanib Capsules in dosage form will be 3004.90.9216, HarmonizedTariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed orunmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packingsfor retail sale: Other: Other: Other: Antineoplastic and immunosuppressive medicaments.” The general rateof 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 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 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.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

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