Federal Register NoticeDermatology

FDA Approval: ZYRTEC HIVES (CETIRIZINE HYDROCHLORIDE) — Type 1 - New Molecular Entity

FDA-NDA019835

Document details

Document type
Federal Register Notice
Issuing body
Office of the Federal Register / NARA
Document ID
FDA-NDA019835
Published
June 17, 2026
Effective date
December 8, 1995
MAC region
National

Summary

CETIRIZINE HYDROCHLORIDE, marketed as ZYRTEC HIVES, is an oral drug and will be billed under Medicare Part D. Given that it is not an injectable drug, no J-code will be assigned, and typical reimburse

Newly approved ZYRTEC HIVES impacts Medicare Part D billing.

Affected specialty

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Source document

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019835

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