CLA-2-30:OT:RR:NC:N3:138

Mr. Pradeep Shah
Zydus Pharmaceuticals USA Inc.
73 Route 31 North
Pennington, NJ 08534

RE: The tariff classification of Cyanocobalamin Injection in dosage form, from France

Dear Mr. Shah:

In your letter dated March 26, 2021, you requested a tariff classification ruling.

Cyanocobalamin Injection is a synthetic form of Vitamin B12 that is indicated for the treatment of Vitamin B12 deficiencies due to malabsorption which may be associated with Addisonian (pernicious) anemia, gastrointestinal pathology, small bowel bacterial overgrowth, fish tapeworm infestation, malignancy of the pancreas or bowel and folic acid deficiency. Cyanocobalamin Injection will be imported in 1,000 mcg/mL single-dose vials, 10,000 mcg/10 mL multiple-dose vials, and 30,000 mcg/30 mL multiple-dose vials.

The applicable subheading for Cyanocobalamin Injection in dosage form will be 3004.50.5020, 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 containing vitamins or other products of heading 2936: Other: Other: Single vitamins: Other.” The rate of duty will be free.

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 on the World Wide Web at https://hts.usitc.gov/current.

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.

This ruling is being issued under the provisions of Part 177 of the Customs 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, contact National Import Specialist Judy Lee at [email protected].

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division