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OXYCODONE HYDROCHLORIDE 40 mg Tablet, Film Coated, Extended Release, 100-count — NDC 00115-1560-01 package photo

OXYCODONE HYDROCHLORIDE 40 mg Tablet, Film Coated, Extended Release, 100-count

by Amneal Pharmaceuticals of New York LLC · 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1560-01)
NDC 00115-1560-01
🏷️ FDA NDC (as labeled) 0115-1560-01 billing pads the labeler segment with a zero
Rx only Brand On market CII 🛡 REMS
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Oxycodone Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 14, 2026 — Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. (Amerisource Health Services LLC) · FDA recall D-0338-2026
Class III · Oct 20, 2023 — Sub-potent Drug: Lower potency than labeled. (Zyla Life Sciences US Inc.) · FDA recall D-0094-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0115-1560-01
Product NDC 0115-1560
11-digit billing NDC 00115156001
NCPDP billing unit EA — each (per item)
RxCUI 1860127, 1860129, 1860137, 1860148, 1860151, 1860154, 1860157
UNII C1ENJ2TE6C
UPC 0301151561014
Application # NDA022272
SPL Set ID c2c57ae7-86b9-47bb-a31b-ed1c4327ce7f
Established class (EPC) Opioid Agonist
Mechanism of action Full Opioid Agonists
DEA schedule CII
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-02-22
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance OXYCODONE HYDROCHLORIDE
GPI-14 6510007510A740
GPI class oxyCODONE HCl ER
GCN Seq No 072866
GCN 37163
HICL code 001742
Ingredient (HICL) Oxycodone Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3A
Therapeutic class — specific (HIC3) Opioid Analgesics
AHFS code 28:08.08.00
AHFS class Opioid Agonists (28:08)
FDB label name OXYCODONE HCL ER 40 MG TABLET
FDB brand name Oxycodone Hcl Er
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0115-1560-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00115-1560-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Natural opium alkaloids
How it works Full Opioid Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAmneal Pharmaceuticals of New York LLC
Application holderKNOA PHARMA LLC
FDA applicationNDA022272 (NDA AUTHORIZED GENERIC)
Labeler code00115
First marketedFeb 2016
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio228 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name OXYCODONE HCL ER 40 MG TABLET Ingredient Oxycodone Hcl
📗 Our plain-language guide HelloPharmacist
  • Extended-release oxycodone is designed for pain that's severe enough to need steady, around-the-clock control — not just occasional flare-ups. The tablet releases slowly over 12 ho...
  • Why has my doctor prescribed an extended-release opioid instead of regular pain pills?
  • No — and this is really important. Crushing, breaking, chewing, or dissolving the tablet destroys the controlled-release mechanism. The entire dose, meant to be released slowly ove...
  • Is it okay to crush or break the tablet to make it easier to swallow?
📖 Read our full Oxycodone guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $5.670 $567.02 / 100 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Nov 2021 $5.670 $5.670
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oxycodone Hydrochloride 40 mgthis 00115-1560-01 Amneal 100 tablets $5.670 — FDA listed —
OxyContin 40 mg 59011-0440-10 Knoa 100 tablets $18.777 — Availability likely +231%
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2010
First FDA approval
Apr 2010
📍
2026
Currently FDA-listed
16 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2030. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 5, 2010 RLD RS ⏳ ~3.5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8808741 — method of use (U-1556)
US 8808741 — method of use (U-1556)
US 8808741 — method of use (U-1556)
US 8808741 — method of use (U-1556)
US 9492393 — method of use (U-1556)
US 9492393 — method of use (U-1556)
US 9492393 — method of use (U-1556)
US 9492393 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 8808741 — method of use (U-1556)
US 8808741 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 9492393 — method of use (U-1556)
US 9492393 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 9492393 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 9492391 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 11304909 — method of use (U-1556)
US 8808741 — method of use (U-1556)
US 9492392 — drug product
US 12246094 — drug product
US 9775808 — drug product
US 9775808 — drug product
US 9770416 — drug product
US 8894987 — drug product
US 11964056 — drug product
US 9763933 — drug product
US 9770416 — drug product
US 8894988 — drug product
US 11964056 — drug product
US 9770416 — drug product
US 12280152 — drug product
US 9492389 — drug product
US 12280152 — drug product
US 9775808 — drug product
US 12246094 — drug product
US 9775808 — drug product
US 12246094 — drug product
US 11964056 — drug product
US 8894988 — drug product
US 9763933 — drug product
US 9775808 — drug product
US 9492389 — drug product
US 11304908 — drug product
US 9775808 — drug product
US 8894987 — drug product
US 9770416 — drug product
US 8894987 — drug product
US 9492392 — drug product
US 9770416 — drug product
US 12280152 — drug product
US 8894988 — drug product
US 11304908 — drug product
US 12280152 — drug product
US 12246094 — drug product
US 12246094 — drug product
US 11964056 — drug product
US 11304908 — drug product
US 11304908 — drug product
US 9763933 — drug product
US 9770416 — drug product
US 9763933 — drug product
US 9492392 — drug product
US 9492392 — drug product
US 12280152 — drug product
US 11304908 — drug product
US 9775808 — drug product
US 9492389 — drug product
US 9492389 — drug product
US 11304908 — drug product
US 9492389 — drug product
US 9492392 — drug product
US 9763933 — drug product
US 9763933 — drug product
US 12280152 — drug product
US 8894988 — drug product
US 11304908 — drug product
US 8894988 — drug product
US 11964056 — drug product
US 9492389 — drug product
US 12246094 — drug product
US 11964056 — drug product
US 12246094 — drug product
US 9492392 — drug product
US 9492389 — drug product
US 9492392 — drug product
US 11964056 — drug product
US 8894988 — drug product
US 12280152 — drug product
US 9770416 — drug product
US 9763933 — drug product
US 8894988 — drug product
US 8894987 — drug product
2010 2012 2014 2016 2018 2020 2022 2024 2026 2028 2030
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (102)
PatentTypeUse codeExpires
US 8808741 ↗ Method of use U-1556 Aug 24, 2027
US 8808741 ↗ Method of use U-1556 Aug 24, 2027
US 8808741 ↗ Method of use U-1556 Aug 24, 2027
US 8808741 ↗ Method of use U-1556 Aug 24, 2027
US 9492393 ↗ Method of use U-1556 Aug 24, 2027
US 9492393 ↗ Method of use U-1556 Aug 24, 2027
US 9492393 ↗ Method of use U-1556 Aug 24, 2027
US 9492393 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 8808741 ↗ Method of use U-1556 Aug 24, 2027
US 8808741 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 9492393 ↗ Method of use U-1556 Aug 24, 2027
US 9492393 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 9492393 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 9492391 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 11304909 ↗ Method of use U-1556 Aug 24, 2027
US 8808741 ↗ Method of use U-1556 Aug 24, 2027
US 9492392 ↗ Drug product — Aug 24, 2027
US 12246094 ↗ Drug product — Aug 24, 2027
US 9775808 ↗ Drug product — Aug 24, 2027
US 9775808 ↗ Drug product — Aug 24, 2027
US 9770416 ↗ Drug product — Aug 24, 2027
US 8894987 ↗ Drug product — Mar 29, 2030
US 11964056 ↗ Drug product — Aug 24, 2027
US 9763933 ↗ Drug product — Aug 24, 2027
US 9770416 ↗ Drug product — Aug 24, 2027
US 8894988 ↗ Drug product — Aug 24, 2027
US 11964056 ↗ Drug product — Aug 24, 2027
US 9770416 ↗ Drug product — Aug 24, 2027
US 12280152 ↗ Drug product — Aug 24, 2027
US 9492389 ↗ Drug product — Aug 24, 2027
US 12280152 ↗ Drug product — Aug 24, 2027
US 9775808 ↗ Drug product — Aug 24, 2027
US 12246094 ↗ Drug product — Aug 24, 2027
US 9775808 ↗ Drug product — Aug 24, 2027
US 12246094 ↗ Drug product — Aug 24, 2027
US 11964056 ↗ Drug product — Aug 24, 2027
US 8894988 ↗ Drug product — Aug 24, 2027
US 9763933 ↗ Drug product — Aug 24, 2027
US 9775808 ↗ Drug product — Aug 24, 2027
US 9492389 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
US 9775808 ↗ Drug product — Aug 24, 2027
US 8894987 ↗ Drug product — Mar 29, 2030
US 9770416 ↗ Drug product — Aug 24, 2027
US 8894987 ↗ Drug product — Mar 29, 2030
US 9492392 ↗ Drug product — Aug 24, 2027
US 9770416 ↗ Drug product — Aug 24, 2027
US 12280152 ↗ Drug product — Aug 24, 2027
US 8894988 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
US 12280152 ↗ Drug product — Aug 24, 2027
US 12246094 ↗ Drug product — Aug 24, 2027
US 12246094 ↗ Drug product — Aug 24, 2027
US 11964056 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
US 9763933 ↗ Drug product — Aug 24, 2027
US 9770416 ↗ Drug product — Aug 24, 2027
US 9763933 ↗ Drug product — Aug 24, 2027
US 9492392 ↗ Drug product — Aug 24, 2027
US 9492392 ↗ Drug product — Aug 24, 2027
US 12280152 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
US 9775808 ↗ Drug product — Aug 24, 2027
US 9492389 ↗ Drug product — Aug 24, 2027
US 9492389 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
US 9492389 ↗ Drug product — Aug 24, 2027
US 9492392 ↗ Drug product — Aug 24, 2027
US 9763933 ↗ Drug product — Aug 24, 2027
US 9763933 ↗ Drug product — Aug 24, 2027
US 12280152 ↗ Drug product — Aug 24, 2027
US 8894988 ↗ Drug product — Aug 24, 2027
US 11304908 ↗ Drug product — Aug 24, 2027
US 8894988 ↗ Drug product — Aug 24, 2027
US 11964056 ↗ Drug product — Aug 24, 2027
US 9492389 ↗ Drug product — Aug 24, 2027
US 12246094 ↗ Drug product — Aug 24, 2027
US 11964056 ↗ Drug product — Aug 24, 2027
US 12246094 ↗ Drug product — Aug 24, 2027
US 9492392 ↗ Drug product — Aug 24, 2027
US 9492389 ↗ Drug product — Aug 24, 2027
US 9492392 ↗ Drug product — Aug 24, 2027
US 11964056 ↗ Drug product — Aug 24, 2027
US 8894988 ↗ Drug product — Aug 24, 2027
US 12280152 ↗ Drug product — Aug 24, 2027
US 9770416 ↗ Drug product — Aug 24, 2027
US 9763933 ↗ Drug product — Aug 24, 2027
US 8894988 ↗ Drug product — Aug 24, 2027
US 8894987 ↗ Drug product — Mar 29, 2030
Common questions
Is there a generic version of OXYCODONE HCL ER 40 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for OXYCODONE HCL ER 40 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2030 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🛡
This drug has a REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It may require enrollment, counseling, or monitoring to manage a serious risk. See the boxed warning & full label below, and REMS@FDA ↗.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Oxycodone Hydrochloride — the ingredient across all brands.

Top reported reactions

Drug Dependence101,882
Pain61,078
Overdose56,283
Emotional Distress49,398
Drug Withdrawal Syndrome37,426
Death27,705
Dependence20,302

Age at onset

Neonate2,709
Infant173
Child396
Adolescent281
Adult13,608
Elderly5,378

Reporter sex

283,386 reports
Male · 51%
Female · 49%
Unknown · 0%

Serious outcomes

Death59,826
Hospitalization52,343
Life-threatening7,523
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 36,805 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
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📄 Full prescribing information FDA SPL

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🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~3 min read ▾

WARNING: ADDICTION, ABUSE AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Oxycodone HCl extended-release tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing oxycodone HCl extended-release tablets and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ] .

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings and Precautions (5.2) ] . Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of oxycodone HCl extended-release tablets. Monitor for respiratory depression, especially during initiation of oxycodone HCl extended-release tablets or following a dose increase. Instruct patients to swallow oxycodone HCl extended-release tablets whole; crushing, chewing, or dissolving oxycodone HCl extended-release tablets can cause rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions (5.3) ] .

Accidental Ingestion Accidental ingestion of even one dose of oxycodone HCl extended-release tablets, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions (5.3) ] . Neonatal Opioid Withdrawal Syndrome Prolonged use of oxycodone HCl extended-release tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.4) ] .

Cytochrome P450 3A4 Interaction The concomitant use of oxycodone HCl extended-release tablets with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving oxycodone HCl extended-release tablets and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.5) , Drug Interactions (7) , Clinical Pharmacology (12.3) ] .

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.6) , Drug Interactions (7) ] . Reserve concomitant prescribing of oxycodone HCl extended-release tablets and benzodiazepines or other CNS depres…

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Oxycodone HCl extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in: Adults; and Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1) ] , reserve oxycodone HCl extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Oxycodone HCl extended-release tablets are not indicated as an as-needed (prn) analgesic. Oxycodone HCl extended-release tablets are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in: Adults; and Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.

Limitations of Use Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxycodone HCl extended-release tablets for use in patients for whom alternative treatment options (e.g. non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 ) Oxycodone HCl extended-release tablets are not indicated as an as-needed (prn) analgesic.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain. (2.1) Oxycodone HCl extended-release tablets 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. ( 2.1 ) Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.

( 2.1 ) Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( 2.1 ). Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. ( 2.1 ) Instruct patients to swallow tablets intact and not to cut, break, chew, crush, or dissolve tablets (risk of potentially fatal dose).

( 2.1 , 5.1 ) Instruct patients to take tablets one at a time, with enough water to ensure complete swallowing immediately after placing in mouth. ( 2.1 , 5.11 ) Do not abruptly discontinue oxycodone HCl extended-release tablets in a physically dependent patient. ( 2.9 ) Adults : For opioid-naïve and opioid non-tolerant patients, initiate with 10 mg tablets orally every 12 hours.

See full prescribing information for instructions on conversion from opioids to oxycodone HCl extended-release tablets, titration and maintenance of therapy. ( 2.2 , 2.3 , 2.5 ) Pediatric Patients 11 Years of Age and Older For use only in pediatric patients 11 years and older already receiving and tolerating opioids for at least 5 consecutive days with a minimum of 20 mg per day of oxycodone or its equivalent for at least two days immediately preceding dosing with oxycodone HCl extended-release tablets. (2.4) See full prescribing information for instructions on conversion from opioids to oxycodone HCl extended-release tablets, titration and maintenance of therapy.

( 2.4 , 2.5 ) Geriatric Patients : In debilitated, opioid non-tolerant geriatric patients, initiate dosing at one third to one half the recommended starting dosage and titrate carefully. ( 2.7 , 8.5 ) Patients with Hepatic Impairment : Initiate dosing at one third to one half the recommended starting dosage and titrate carefully. ( 2.8 , 8.6 )

2.1Important Dosage and Administration Instructions Oxycodone HCl extended-release tablets should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Oxycodone HCl extended-release tablets 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Adult patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.1) ] . Initiate the dosing regimen for each patient individually; taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1) ] . Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with oxycodone HCl extended-release tablets and adjust the dosage accordingly [see Warnings and Precau…

💊 Dosage Forms and Strengths 182 words ▾

3 DOSAGE FORMS AND STRENGTHS Extended-release tablets: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg. 10 mg film-coated extended-release tablets (round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other) 15 mg film-coated extended-release tablets (round, gray-colored, bi-convex tablets debossed with OP on one side and 15 on the other) 20 mg film-coated extended-release tablets (round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other) 30 mg film-coated extended-release tablets (round, brown-colored, bi-convex tablets debossed with OP on one side and 30 on the other) 40 mg film-coated extended-release tablets (round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other) 60 mg film-coated extended-release tablets (round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other) 80 mg film-coated extended-release tablets (round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other Extended-release tablets: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg.

( 3 )

⛔ Contraindications 107 words ▾

4 CONTRAINDICATIONS Oxycodone HCl extended-release tablets are contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.3) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.7) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12) ] Hypersensitivity (e.g., anaphylaxis) to oxycodone [see Adverse Reactions (6.2) ] Significant respiratory depression.

( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) Hypersensitivity to oxycodone.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. ( 5.7 ) Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.8 ) Severe Hypotension: Monitor during dosage initiation and titration.

Avoid use of oxycodone HCl extended-release tablets in patients with circulatory shock. ( 5.9 ) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of oxycodone HCl extended-release tablets in patients with impaired consciousness or coma.

( 5.10 ) Risk of Obstruction in Patients who have Difficulty Swallowing or have Underlying GI Disorders that may Predispose them to Obstruction: Consider use of an alternative analgesic. ( 5.11 )

5.1Addiction, Abuse, and Misuse Oxycodone HCl extended-release tablets contains oxycodone, a Schedule II controlled substance. As an opioid, oxycodone HCl extended-release tablets expose users to the risks of addiction, abuse, and misuse. Because extended-release products such as oxycodone HCl extended-release tablets deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxycodone present [see Drug Abuse and Dependence (9) ] .

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed oxycodone HCl extended-release tablets. Addiction can occur at recommended doses and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing oxycodone HCl extended-release tablets, and monitor all patients receiving oxycodone HCl extended-release tablets for the development of these behaviors and conditions.

Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as oxycodone HCl extended-release tablets, but use in such patients necessitates intensive counseling about the risks and proper use of oxycodone HCl extended-release tablets along with intensive monitoring for signs of addiction, abuse, and misuse.

Abuse or misuse of oxycodone HCl extended-release tablets by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of oxycodone and can result in overdose and death [see Overdosage (10) ] . Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing oxycodone HCl extended-release tablets.

Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information (17) ] . Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

5.2Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to do all of the following: Complete a REMS-compliant education program offered by an accredi…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Interactions With Benzodiazepines and Other CNS Depressants [see Warnings and Precautions (5.6) ] Adrenal Insufficiency [see Warnings and Precautions (5.8) ] Severe Hypotension [see Warnings and Precautions (5.9) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.11 , 5.12) ] Seizures [see Warnings and Precautions (5.13) ] Withdrawal [see Warnings and Precautions (5.14) ] Most common adverse reactions (incidence >5%) were constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trial Experience Adult Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of oxycodone HCl extended-release tablets was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies. In open-label studies of cancer pain, 187 patients received oxycodone HCl extended-release tablets in total daily doses ranging from 20 mg to 640 mg per day.

The average total daily dose was approximately 105 mg per day. Oxycodone HCl extended-release tablets may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock [see Overdosage (10) ] . The most common adverse reactions (>5%) reported by patients in clinical trials comparing oxycodone HCl extended-release tablets with placebo are shown in Table 2 below: T able 2: Common Adverse Reactions (>5%) Adverse Reaction Oxycodone HCl extended-release tablets (n=227) Placebo (n=45) (%) (%) Constipation (23) (7) Nausea (23) (11) Somnolence (23) (4) Dizziness (13) (9) Pruritus (13) (2) Vomiting (12) (7) Headache (7) (7) Dry Mouth (6) (2) Asthenia (6) - Sweating (5) (2) In clinical trials, the following adverse reactions were reported in patients treated with oxycodone HCl extended-release tablets with an incidence between 1% and 5%: Gastrointestinal disorders: abdominal pain, diarrhea, dyspepsia, gastritis General disorders and administration site conditions: chills, fever Metabolism and nutrition disorders: anorexia Musculoskeletal and connective tissue disorders: twitching Psychiatric disorders: abnormal dreams, anxiety, confusion, dysphoria, euphoria, insomnia, nervousness, thought abnormalities Respiratory, thoracic and mediastinal disorders: dyspnea, hiccups Skin and subcutaneous tissue disorders : rash Vascular disorders : postural hypotension The following adverse reactions occurred in less than 1% of patients involved in clinical trials: Blood and lymphatic system disorders : lymphadenopathy Ear and labyrinth disorders: tinnitus Eye disorders: abnormal vision Gastrointestinal disorders: dysphagia, eructation, flatulence, gastrointestinal disorder, increased appetite, stomatitis General disorders and administration site conditions: withdrawal syndrome (with and without seizures), edema, peripheral edema, thirst, malaise, chest pain, facial edema Injury, poisoning and procedural complications: accidental injury Investigations: ST depression Metabolism and nutrition disorders: dehydration Nervous system disorders: syncope, migraine, abnormal gait, amnesia, hyperkinesia, hypoesthesia, hypotonia, paresthesia, speech disorder, stupor, tremor…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 4 includes clinically significant drug interactions with oxycodone HCl extended-release tablets. Table 4: Clinically Significant Drug Interactions with Oxycodone HCl Extended-Release Tablets Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of oxycodone HCl extended-release tablets and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of oxycodone HCl extended-release tablets and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of oxycodone HCl extended-release tablets is achieved [see Warnings and Precautions (5.5) ] .

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see Clinical Pharmacology (12.3) ] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to oxycodone. Intervention: If concomitant use is necessary, consider dosage reduction of oxycodone HCl extended-release tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.

If a CYP3A4 inhibitor is discontinued, consider increasing the oxycodone HCl extended-release tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. Examples Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir) CYP3A4 Inducers Clinical Impact: The concomitant use of oxycodone HCl extended-release tablets and CYP3A4 inducers can decrease the plasma concentration of oxycodone [see Clinical Pharmacology (12.3) ] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oxycodone [see Warnings and Precautions (5.5) ] .

After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see Clinical Pharmacology (12.3) ] , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. Intervention: If concomitant use is necessary, consider increasing the oxycodone HCl extended-release tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.

If a CYP3A4 inducer is discontinued, consider oxycodone HCl extended-release tablets dosage reduction and monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see Dosage and Administration (2.6) , Warnings and Precautions (5.6) ] . Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.

Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome . Intervention: If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue oxycodone HCl extended-release tablets if serotonin syndrome is suspected.

Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : May cause fetal harm. ( 8.1 ) Lactation : Not recommended. ( 8.2 )

8.1Pregnancy Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4) ] . There are no available data with oxycodone HCl extended-release tablets in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, there was no embryo-fetal toxicity when oxycodone hydrochloride was orally administered to rats and rabbits, during the period of organogenesis, at doses 1.3 to 40 times the adult human dose of 60 mg/day, respectively.

In a pre- and postnatal toxicity study, when oxycodone was orally administered to rats, there was transiently decreased pup body weight during lactation and the early post-weaning period at the dose equivalent to an adult dose of 60 mg/day. In several published studies, treatment of pregnant rats with oxycodone hydrochloride at clinically relevant doses and below resulted in neurobehavioral effects in offspring [see Data] . Based on animal data, advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn.

Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.4) ] . Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate.

Oxycodone HCl extended-release tablets is not recommended for use in women immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics, including oxycodone HCl extended-release tablets, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor.

Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data Pregnant rats were treated with 0.5, 2, 4, and 8 mg/kg oxycodone hydrochloride (0.08, 0.3, 0.7, and 1.3 times the human daily dose of 60 mg/day, respectively based on a mg/m 2 basis) during the period of organogenesis. Oxycodone did not cause adverse effects to the fetus at exposures up to 1.3 times the human dose of 60 mg/day.

The high dose produced maternal toxicity characterized by excessive gnawing on forelimbs and decreased body weight gain. Pregnant rabbits were treated with 1, 5, 25, and 125 mg/kg oxycodone hydrochloride (0.3, 2, 8, and 40 times the human daily dose of 60 mg/day, respectively, based on a mg/m 2 basis) during the period of organogenesis. Oxycodone did not cause adverse effects to the fetus at exposures u…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4) ] . There are no available data with oxycodone HCl extended-release tablets in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, there was no embryo-fetal toxicity when oxycodone hydrochloride was orally administered to rats and rabbits, during the period of organogenesis, at doses 1.3 to 40 times the adult human dose of 60 mg/day, respectively.

In a pre- and postnatal toxicity study, when oxycodone was orally administered to rats, there was transiently decreased pup body weight during lactation and the early post-weaning period at the dose equivalent to an adult dose of 60 mg/day. In several published studies, treatment of pregnant rats with oxycodone hydrochloride at clinically relevant doses and below resulted in neurobehavioral effects in offspring [see Data] . Based on animal data, advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn.

Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.4) ] . Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate.

Oxycodone HCl extended-release tablets is not recommended for use in women immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics, including oxycodone HCl extended-release tablets, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor.

Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data Pregnant rats were treated with 0.5, 2, 4, and 8 mg/kg oxycodone hydrochloride (0.08, 0.3, 0.7, and 1.3 times the human daily dose of 60 mg/day, respectively based on a mg/m 2 basis) during the period of organogenesis. Oxycodone did not cause adverse effects to the fetus at exposures up to 1.3 times the human dose of 60 mg/day.

The high dose produced maternal toxicity characterized by excessive gnawing on forelimbs and decreased body weight gain. Pregnant rabbits were treated with 1, 5, 25, and 125 mg/kg oxycodone hydrochloride (0.3, 2, 8, and 40 times the human daily dose of 60 mg/day, respectively, based on a mg/m 2 basis) during the period of organogenesis. Oxycodone did not cause adverse effects to the fetus at exposures up to 40 times the human dose of 60 mg/day.

The 25 mg/kg and 125 mg/kg doses high doses produced maternal toxi…

🧒 Pediatric Use 193 words ▾

8.4Pediatric Use The safety and efficacy of oxycodone HCl extended-release tablets have been established in pediatric patients ages 11 to 16 years. Use of oxycodone HCl extended-release tablets is supported by evidence from adequate and well-controlled trials with oxycodone HCl extended-release tablets in adults as well as an open-label study in pediatric patients ages 6 to 16 years. However, there were insufficient numbers of patients less than 11 years of age enrolled in this study to establish the safety of the product in this age group.

The safety of oxycodone HCl extended-release tablets in pediatric patients was evaluated in 155 patients previously receiving and tolerating opioids for at least 5 consecutive days with a minimum of 20 mg per day of oxycodone or its equivalent on the two days immediately preceding dosing with oxycodone HCl extended-release tablets. Patients were started on a total daily dose ranging between 20 mg and 100 mg depending on prior opioid dose. The most frequent adverse events observed in pediatric patients were vomiting, nausea, headache, pyrexia, and constipation [see Dosage and Administration (2.4) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) and Clinical Trials (14) ] .

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use In controlled pharmacokinetic studies in elderly subjects (greater than 65 years) the clearance of oxycodone was slightly reduced. Compared to young adults, the plasma concentrations of oxycodone were increased approximately 15% [see Clinical Pharmacology (12.3) ] . Of the total number of subjects (445) in clinical studies of oxycodone hydrochloride controlled-release tablets, 148 (33.3%) were age 65 and older (including those age 75 and older) while 40 (9.0%) were age 75 and older.

In clinical trials with appropriate initiation of therapy and dose titration, no untoward or unexpected adverse reactions were seen in the elderly patients who received oxycodone hydrochloride controlled-release tablets. Thus, the usual doses and dosing intervals may be appropriate for elderly patients. However, a dosage reduction in debilitated, non-opioid-tolerant patients is recommended [see Dosage and Administration (2.7) ] .

Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who are not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of oxycodone HCl extended-release tablets slowly in these patients and monitor closely for signs of central nervous system and respiratory depression. [see Warnings and Precautions (5.7) ] . Oxycodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Clinical Presentation Acute overdose with oxycodone HCl extended-release tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations. Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed.

Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose.

For clinically significant respiratory or circulatory depression secondary to oxycodone overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose. Because the duration of reversal is expected to be less than the duration of action of oxycodone in oxycodone HCl extended-release tablets, carefully monitor the patient until spontaneous respiration is reliably reestablished.

Oxycodone HCl extended-release tablets will continue to release oxycodone and add to the oxycodone load for 24 to 48 hours or longer following ingestion, necessitating prolonged monitoring. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome.

The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Oxycodone is a full opioid agonist and is relatively selective for the mu receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect to analgesia for oxycodone.

Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

12.2Pharmacodynamics Effects on the Central Nervous System Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in CO 2 tension and electrical stimulation. Oxycodone causes miosis, even in total darkness.

Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Overdosage (10) ] . Effects on the Gastrointestinal Tract and Other Smooth Muscle Oxycodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.

Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.

Effects on the Cardiovascular System Oxycodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see Adverse Reactions (6.2)] .

They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions (6.2) ] .

Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.

Concentration –Efficacy Relationships Studies in normal volunteers and patients reveal predictable relationships between oxycodone dosage and plasma oxycodone concentrations, as well as between concentration and certain expected opioid effects, such as pupillary constriction, sedation, overall subjective “drug effect”, analgesia and feelings of relaxation. The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids.

The minimum effective analgesic concentration of oxycodone for any individual patient may increase over time due to an…

🧬 Mechanism of Action 114 words ▾

12.1Mechanism of Action Oxycodone is a full opioid agonist and is relatively selective for the mu receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect to analgesia for oxycodone.

Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Oxycodone HCl Extended-Release Tablets 10 mg are film-coated, round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1556-01). Oxycodone HCl Extended-Release Tablets 15 mg are film-coated, round, gray-colored, bi-convex tablets debossed with OP on one side and 15 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1557-01) Oxycodone HCl Extended-Release Tablets 20 mg are film-coated, round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1558-01) Oxycodone HCl Extended-Release Tablets 30 mg are film-coated, round, brown-colored, bi-convex tablets debossed with OP on one side and 30 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1559-01) Oxycodone HCl Extended-Release Tablets 40 mg are film-coated, round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1560-01) Oxycodone HCl Extended-Release Tablets 60 mg are film-coated, round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1561-01) Oxycodone HCl Extended-Release Tablets 80 mg are film-coated, round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1562-01) Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in tight, light-resistant container.

📋 Description ~1 min read ▾

11 DESCRIPTION Oxycodone HCl extended-release tablets are an opioid agonist supplied in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows: C 18 H 21 NO 4 ∙ HCl MW 351.83 The chemical name is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.

Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7).

The 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg tablets contain the following inactive ingredients: butylated hydroxytoluene (BHT), hypromellose, polyethylene glycol 400, polyethylene oxide, magnesium stearate, titanium dioxide. The 10 mg tablets also contain hydroxypropyl cellulose. The 15 mg tablets also contain black iron oxide, yellow iron oxide, and red iron oxide.

The 20 mg tablets also contain polysorbate 80 and red iron oxide. The 30 mg tablets also contain polysorbate 80, red iron oxide, yellow iron oxide, and black iron oxide. The 40 mg tablets also contain polysorbate 80 and yellow iron oxide.

The 60 mg tablets also contain polysorbate 80, red iron oxide and black iron oxide. The 80 mg tablets also contain hydroxypropyl cellulose, yellow iron oxide and FD&C Blue #2/Indigo Carmine Aluminum Lake. chemical structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Addiction, Abuse and Misuse Inform patients that the use of oxycodone HCl extended-release tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1) ] . Instruct patients not to share oxycodone HCl extended-release tablets with others and to take steps to protect oxycodone HCl extended-release tablets from theft or misuse.

Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting oxycodone HCl extended-release tablets or when the dosage is increased, and that it can occur even at recommended dosages [see Warnings and Precautions (5.3) ] . Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop. To guard against excessive exposure to oxycodone HCl extended-release tablets by young children, advise caregivers to strictly adhere to recommended oxycodone HCl extended-release tablets dosing.

Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.3) ] . Instruct patients to take steps to store oxycodone HCl extended-release tablets securely and to dispose of unused oxycodone HCl extended-release tablets by flushing the tablets down the toilet. Interactions with Benzodiazepines or Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if oxycodone HCl extended-release tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions (5.6) , Drug Interactions (7) ].

Serotonin Syndrome Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare provider if they are taking, or plan to take serotonergic medications [see Drug Interactions (7) ] .

MAOI Interaction Inform patients to avoid taking oxycodone HCl extended-release tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking oxycodone HCl extended-release tablets [see Drug Interactions (7) ] . Adrenal Insufficiency Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition.

Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.8) ] . Important Administration Instructions Instruct patients how to properly take oxycodone HCl extended-release tablets, including the following: Oxycodone HCl extended-release tablets are designed to work properly only if swallowed intact.

Taking cut, broken, chewed, crushed, or dissolved oxycodone HCl extended-release tablets can result in a fatal overdose [see Dosage and Administration (2.1) ] . Oxycodone HCl extended-release tablets should be taken one tablet at a time [see Dosage and Administration (2.1) ] . Do not pre-soak, lick, or otherwise wet the tablet prior to placing in the mouth [see Dosage and Administration (2.1) ] .

Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth [see Dosage and Administration (2.1) ] . Do not discontinue oxycodone HCl extended-release tablets without first discussing the need for a tapering regimen with the prescriber [see Dos…

💬 Medication Guide ~3 min read ▾

Medication Guide Oxycodone ( OX-ee-KOH-dohn ) HCl Extended-Release Tablets, CII Oxycodone HCl extended-release tablets are: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them. A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death.

Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Not for use to treat pain that is not around-the-clock. Not for use in children less than 11 years of age and who are not already using opioid pain medicines regularly to manage pain severe enough to require daily around-the-clock long-term treatment of pain with an opioid.

Important information about oxycodone HCl extended-release tablets: Get emergency help right away if you take too much oxycodone HCl extended-release tablets (overdose). When you first start taking oxycodone HCl extended-release tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Taking oxycodone HCl extended-release tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Never give anyone else your oxycodone HCl extended-release tablets. They could die from taking it. Store oxycodone HCl extended-release tablets away from children and in a safe place to prevent stealing or abuse.

Selling or giving away oxycodone HCl extended-release tablets is against the law. Do not take oxycodone HCl extended-release tablets if you have: severe asthma, trouble breathing, or other lung problems. a bowel blockage or have narrowing of the stomach or intestines. Before taking oxycodone HCl extended-release tablets, tell your healthcare provider if you have a history of: head injury, seizures liver, kidney, thyroid problems problems urinating pancreas or gallbladder problems abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are: pregnant or planning to become pregnant. Prolonged use of oxycodone HCl extended-release tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. breastfeeding. Not recommended during treatment with oxycodone HCl extended-release tablets.

It may harm your baby. taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking oxycodone HCl extended-release tablets with certain other medicines can cause serious side effects that could lead to death. When taking oxycodone HCl extended-release tablets: Do not change your dose.

Take oxycodone HCl extended-release tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. Take your prescribed dose every 12 hours at the same time every day.

Do not take more than your prescribed dose in 12 hours. If you miss a dose, take your next dose at your usual time. Swallow oxycodone HCl extended-release tablets whole.

Do not cut, break, chew, crush, dissolve, snort, or inject oxycodone HCl extended-release tablets because this may cause you to overdose and die. Oxycodone HCl extended-release tablets should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing in your mouth to avoid choking on the tablet.

Call your healthcare provider if the dose you are taking does not control your pain. Do not stop taking oxycodone HCl extended-release tablets without talking to your healthcare provider. After you stop t…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.