Federal Register NoticePain Management

FDA Approval: OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE) — Type 7 - Drug Already Marketed without Approved NDA

FDA-NDA200535

Document details

Document type
Federal Register Notice
Issuing body
Office of the Federal Register / NARA
Document ID
FDA-NDA200535
Published
June 24, 2026
Effective date
October 20, 2010
MAC region
National

Summary

The billing pathway for Oxycodone Hydrochloride is Part D due to its oral route of administration. Billing teams need to ensure they follow the correct procedures for outpatient prescription coverage

Oxycodone Hydrochloride approved; monitor Part D billing.

Affected specialty

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Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200535s000lbl.pdf

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