FDA label
What is Endocet used for?
Endocet contains oxycodone and acetaminophen. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
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Endocet, tablet
Indications and Usage, quoted from the label by Par Health USA, LLC (ANDA040330). Cross-references to other label sections are left out.
ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use:
- Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Source: DailyMed label, set id 944d3e60-7eee-11de-a413-0002a5d5c51b, version 55, effective December 1, 2025. NDC 60951-602, one of 8 listings for this product.
Questions
What is Endocet used for?
The FDA label says: “ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
What drug class is Endocet?
FDA lists oxycodone and acetaminophen in the Opioid Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Endocet
- Is Endocet a controlled substance?Schedule II
- What is Oxycodone and Acetaminophen used for?FDA label uses
- Is Oxycodone and Acetaminophen a controlled substance?Schedule II
- Opioid Agonists listFDA drug class
- NDC 60951-602Endocet NDC record
- NDC 60951-700Endocet NDC record
- NDC 60951-701Endocet NDC record
- Schedule II drugs listDEA schedule