Federal Register NoticePain Management

FDA Approval: TAPENTADOL (TAPENTADOL HYDROCHLORIDE) — Type 1 - New Molecular Entity

FDA-NDA022304

Document details

Document type
Federal Register Notice
Issuing body
Office of the Federal Register / NARA
Document ID
FDA-NDA022304
Published
June 24, 2026
Effective date
November 20, 2008
MAC region
National

Summary

The drug tapentadol hydrochloride is administered orally and is classified under Part D of Medicare billing. Billing teams should verify against the FDA label for any specific billing details once pub

New oral tapentadol hydrochloride now available for billing.

Affected specialty

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Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022304s000lbl_v2.pdf

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