Federal Register NoticePain Management

FDA Approval: TAPENTADOL (TAPENTADOL HYDROCHLORIDE) — Type 3 - New Dosage Form

FDA-NDA200533

Document details

Document type
Federal Register Notice
Issuing body
Office of the Federal Register / NARA
Document ID
FDA-NDA200533
Published
June 23, 2026
Effective date
August 25, 2011
MAC region
National

Summary

The billing pathway for tapentadol is confirmed as Part D since it is an oral extended-release tablet. Medicare billing teams should ensure they are aligned with the latest formulary updates to confir

New oral tapentadol formulation impacts Part D billing.

Affected specialty

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Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200533s000lbl.pdf

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