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Oxymorphone hydrochloride 20 mg Tablet, Film Coated, Extended Release, 1,000-count

by Amneal Pharmaceuticals of New York LLC · 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1233-03)

NDC 00115-1233-03

🏷️ FDA NDC (as labeled) 0115-1233-03 billing pads the labeler segment with a zero

This package

Contains1,000-count Pack sizes4 compare ↓

Also priced by: Part D plans $3.94/unit — full pricing hub ↓

Also comes in: 30 tablets 00115-1233-08 60 tablets 00115-1233-13 100 tablets 00115-1233-01

Rx only Generic 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 0115-1233-03

Product NDC 0115-1233

11-digit billing NDC 00115123303

RxCUI 977874, 977894, 977902, 977909, 977915, 977923, 977929

UNII 5Y2EI94NBC

Application # ANDA079087

SPL Set ID 557e9610-62d7-42bf-90c1-44215bd8c1f8

Established class (EPC) Opioid Agonist

Mechanism of action Full Opioid Agonists

DEA schedule CII

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2013-01-02

Route ORAL

Dosage form TABLET, FILM COATED, EXTENDED RELEASE

Substance OXYMORPHONE HYDROCHLORIDE

GPI-14 65100080107420

GPI class oxyMORphone HCl ER

GCN Seq No 061093

GCN 27249

HICL code 001696

Ingredient (HICL) Oxymorphone 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 OXYMORPHONE HCL ER 20 MG TAB

FDB brand name Oxymorphone Hcl Er

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 0115-1233-03 — 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 → 00115-1233-03. 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 holderIMPAX LABORATORIES INC

FDA applicationANDA079087 (ANDA)

Labeler code00115

First marketedJan 2013

DEA scheduleCII

Product typeHuman Prescription Drug

Portfolio228 products on file

🔎 All NDCs from Amneal Pharmaceuticals of New York LLC

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 OXYMORPHONE HCL ER 20 MG TAB Ingredient Oxymorphone Hcl

📖 What it is MedlinePlus · NLM

Oxymorphone is used to relieve severe pain. Oxymorphone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the body responds to pain.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

The regular oxymorphone tablet is meant for short-term, acute pain — the kind that hits hard and needs quick relief for a limited time. You'd take it every four to six hours as nee...
What's the difference between the regular tablet and the extended-release tablet?
It's a real safety point, not just a suggestion. Eating a meal before taking oxymorphone — especially the extended-release version — can raise the amount of drug that gets into you...
Why does my pharmacist keep telling me to take this on an empty stomach?

📖 Read our full Oxymorphone guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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.

💊 What it looks like

Color purple / gray / orange / white / green / brown

ShapeRound

ImprintG74

Size5 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 LMI26O6933
Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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 EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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 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 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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.
UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

14 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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 · Q2 2026	$3.94	$3,936.20 / 1000 tablets

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Oxymorphone hydrochloride 20 mg 64896-0699-01	Amneal	100 tablets	$14.616	—	FDA listed	—
Oxymorphone hydrochloride 20 mgthis 00115-1233-03	Amneal	1000 tablets	—	—	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and 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

🏛️

2013

On the market since

Jan 2013

📍

2026

Currently FDA-listed

13 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 Oxymorphone hydrochloride — the ingredient across all brands.

Top reported reactions

Dependence4,904

Death3,324

Toxicity To Various Agents2,759

Overdose2,310

Drug Dependence583

Drug Abuse551

Back Pain432

Age at onset

Neonate61

Infant1

Child13

Adult29

Elderly9

Reporter sex

Male · 56%

Female · 44%

Serious outcomes

Hospitalization738

Life-threatening25

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
00115-1233-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1233-01)	2013-01-02	Active
00115-1233-03 You're viewing this	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1233-03)	2013-01-02	Active
00115-1233-08	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1233-08)	2013-01-02	Active
00115-1233-13	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1233-13)	2013-01-02	Active

You're viewing the largest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 00115-1233-03?

NDC 00115-1233-03 is a 1,000-count package — 1000 tablet, film coated, extended release in 1 bottle.

What is the difference between NDC 00115-1233-03 and NDC 00115-1233-08?

Both are Oxymorphone hydrochloride 20 mg Tablet, Film Coated, Extended Release — the drug itself is identical. NDC 00115-1233-03 is the 1,000-count package, while NDC 00115-1233-08 is the 30 tablets package.

What NDC number is used to bill for this package of Oxymorphone hydrochloride 20 mg Tablet, Film Coated, Extended Release?

Bill NDC 00115-1233-03 — the 11-digit billing format is 00115123303. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 0115-1233-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00115-1233-03, written without dashes as 00115123303. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 00115-1233-03, the first segment (00115) is the labeler code FDA assigned to Amneal Pharmaceuticals of New York LLC; the middle segment (1233) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Amneal Pharmaceuticals of New York LLC. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 3 other package presentations of this same product, including 30 tablets (00115-1233-08), 60 tablets (00115-1233-13), 100 tablets (00115-1233-01). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Amneal Pharmaceuticals of New York LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 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 ~2 min read ▾

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of Oxymorphone Hydrochloride 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 and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Oxymorphone Hydrochloride Extended-Release Tablets, especially during initiation or following a dosage increase.

To reduce the risk of respiratory depression, proper dosing and titration of Oxymorphone Hydrochloride Extended-Release Tablets are essential [see Warnings and Precautions (5.2) ] . Instruct patients to swallow Oxymorphone Hydrochloride Extended-Release tablets whole to avoid exposure to a potentially fatal dose of oxymorphone. Accidental Ingestion Accidental ingestion of even one dose of Oxymorphone Hydrochloride Extended-Release Tablets, especially by children, can result in a fatal overdose of oxymorphone [see Warnings and Precautions (5.2) ] .

Interaction with Alcohol Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking Oxymorphone Hydrochloride Extended-Release Tablets. The co-ingestion of alcohol with Oxymorphone Hydrochloride Extended-Release Tablets may result in increased plasma levels and a potentially fatal overdose of oxymorphone [see Warnings and Precautions (5.3) ] . 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.

Reserve concomitant prescribing of Oxymorphone Hydrochloride Extended-Release Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3) , Drug Interactions (7) ] . Neonatal Opioid Withdrawal Syndrome (NOWS) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4) ] .

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.5) ]. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS See full prescribing information for complete boxed warning . Oxymorphone Hydrochloride Extended-Release Tablets expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death.

Assess patient's risk before prescribing, and monitor regularly these behaviors and conditions. ( 5.1 ) Serious life-threatening or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.

Instruct patients to swallow Oxymorphone Hydrochloride Extended-Release Tablets whole to avoid exposure to a potentially fatal dose of oxymorphone. ( 5.2 ) Accidental ingestion of Oxymorphone Hydrochloride Extended-Release Tablets, especially by children, can result in fatal overdose of oxymorphone. ( 5.2 ) Instruct patients not to consume alcohol or any product containing alcohol while taking Oxymorphone Hydrochloride Extended-Release Tablets because co-ingestion can result in fatal plasma oxymorphone levels…

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve Oxymorphone Hydrochloride 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 ) Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic. ( 1 ) Limitations of Usage: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1) ] , reserve Oxymorphone Hydrochloride 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.

Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Oxymorphone Hydrochloride Extended-Release Tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Oxymorphone Hydrochloride Extended-Release Tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.

( 2.1 , 5 ) Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1 , 5 ) Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating. ( 2.1 ) Discuss availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with Oxymorphone Hydrochloride Extended-Release Tablets.

Consider prescribing naloxone based on the patient’s risk factors for overdose ( 2.2 , 5.1 , 5.2 , 5.3 ) . For opioid-naïve and opioid non-tolerant patients, initiate treatment with 5 mg tablets orally every 12 hours. ( 2.3 ) To convert to Oxymorphone Hydrochloride Extended-Release Tablets from another opioid, use available conversion factors to obtain estimated dose.

( 2.3 ) Dose can be increased every 3 to 7 days, using increments of 5 mg to 10 mg every 12 hours (i.e., 10 mg to 20 mg per day). (2.4 ) Do not abruptly discontinue Oxymorphone Hydrochloride Extended-Release Tablets in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. ( 2.5 , 5.15 ) Mild Hepatic Impairment: For opioid-naïve patients, initiate treatment with 5 mg and titrate slowly.

For patients on prior opioid therapy, reduce starting dose by 50% and titrate slowly. Monitor for signs of respiratory and central nervous system depression. ( 2.6 ) Renal Impairment: For opioid-naïve patients, initiate treatment with 5 mg and titrate slowly.

For patients on prior opioid therapy, reduce starting dose by 50% and titrate slowly. Monitor for signs of respiratory and central nervous system depression. ( 2.7 ) Geriatric Patients: Initiate dosing with 5 mg, titrate slowly, and monitor for signs of respiratory and central nervous system depression.

( 2.8 )

2.1Important Dosage and Administration Instructions Oxymorphone Hydrochloride Extended-Release Tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5) ] . Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Oxymorphone Hydrochloride Extended-Release Tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.

Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1) ] . Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Oxymorphone Hydrochloride Extended-Release Tablets. Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions (5) ] .

Instruct patients to swallow Oxymorphone Hydrochloride Ext…

💊 Dosage Forms and Strengths 218 words ▾

3 DOSAGE FORMS AND STRENGTHS Oxymorphone Hydrochloride Extended-Release Tablets USP, 5 mg dosage form is a purple, round, film-coated extended-release tablet debossed with "G71" on one side and blank on the other side. Oxymorphone Hydrochloride Extended-Release Tablets USP, 7.5 mg dosage form is a gray, round, film-coated extended-release tablet debossed with "G75" on one side and blank on the other side. Oxymorphone Hydrochloride Extended-Release Tablets USP, 10 mg dosage form is an orange, round, film-coated extended-release tablet debossed with "G72" on one side and blank on the other side.

Oxymorphone Hydrochloride Extended-Release Tablets USP, 15 mg dosage form is a white, round, film-coated extended-release tablet debossed with "G76" on one side and blank on the other side. Oxymorphone Hydrochloride Extended-Release Tablets USP, 20 mg dosage form is a green, round, film-coated extended-release tablet debossed with "G73" on one side and blank on the other side. Oxymorphone Hydrochloride Extended-Release Tablets USP, 30 mg dosage form is a brown, round, film-coated extended-release tablet debossed with "G77" on one side and blank on the other side.

Oxymorphone Hydrochloride Extended-Release Tablets USP, 40 mg dosage form is an orange, round, film-coated extended-release tablet debossed with "G74" on one side and blank on the other side. Extended-release tablets: 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg

⛔ Contraindications 143 words ▾

4 CONTRAINDICATIONS Oxymorphone Hydrochloride 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 (5.6) ] Hypersensitivity (e.g. anaphylaxis) to oxymorphone, any other ingredients in Oxymorphone Hydrochloride Extended-Release Tablets [see Warnings and Precautions (5.7) , Adverse Reactions (6) ]. Moderate and severe hepatic impairment [see Warnings and Precautions (5.9) , Clinical Pharmacology (12.3) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12) ] Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment ( 4 ) Hypersensitivity to oxymorphone ( 4 ) Moderate or severe hepatic impairment ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation. ( 5.6 ) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly Cachectic or Debilitated Patients: Regularly evaluate closely particularly during initiation and titration.

( 5.7 ) Anaphylaxis, Angioedema, and Other Hypersensitivity Reactions: If symptoms occur, stop administration immediately, discontinue permanently, and do not rechallenge with any other oxymorphone formulation. ( 5.8 ) Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 ) Severe Hypotension: Regularly evaluate during dose initiation and titration.

Avoid use of oxymorphone hydrochloride extended-release tablets in patients with circulatory shock. ( 5.11 ) 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 Oxymorphone Hydrochloride Extended-Release Tablets in patients with impaired consciousness or coma.

( 5.12 )

5.1Addiction, Abuse, and Misuse Oxymorphone Hydrochloride Extended-Release Tablet contains, oxymorphone, a Schedule II controlled substance. As an opioid, Oxymorphone Hydrochloride Extended-Release Tablets exposes users to the risks of addiction, abuse, and misuse . Because extended-release products such as Oxymorphone Hydrochloride 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 oxymorphone present [see Drug Abuse and Dependence (9) ] .

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Oxymorphone Hydrochloride 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 Oxymorphone Hydrochloride Extended-Release Tablets and reassess all patients receiving Oxymorphone Hydrochloride 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 Oxymorphone Hydrochloride Extended-Release Tablets, but use in such patients necessitates intensive counseling about the risks and proper use of Oxymorphone Hydrochloride Extended-Release Tablets along with frequent reevaluation for signs of addiction, abuse, and misuse.

Consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration (2.2) and Warnings and Precautions (5.3) ]. Abuse, or misuse of Oxymorphone Hydrochloride Extended-Release Tablets by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the oxymorphone and can result in overdose and death [see Overdosage (10) ] . Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use.

Consider these risks when prescribing or dispensing Oxymorphone Hydrochloride Extended-Release Tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug during the course of treatment and proper disposal of unused drug. Contact local state professional licensing board or state-controlled substances authority…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.2 ) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3 ) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.6) ] Anaphylaxis and Angioedema [see Warnings and Precautions (5.8 ) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Severe Hypotension [see Warnings and Precautions (5.11) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.13) ] Seizures [see Warnings and Precautions (5.14) ] Withdrawal [see Warnings and Precautions (5.15) ] Adverse reactions in ≥2% of patients in placebo-controlled trials: nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, and abdominal pain.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Impax Laboratories, Inc. at 1-800-934-6729 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 clinical practice. The safety of Oxymorphone Hydrochloride Extended-Release Tablets was evaluated in a total of 2011 patients in open-label and controlled clinical trials. The clinical trials enrolled of patients with moderate to severe chronic non-malignant pain, cancer pain, and post surgical pain.

The most common serious adverse events reported with administration of Oxymorphone Hydrochloride Extended-Release Tablets were chest pain, pneumonia and vomiting. Tables 2 and 3 list the most frequently occurring adverse reactions (in at least 5% of patients) from the placebo-controlled trials in patients with low back pain. Table 2: Treatment-Emergent Adverse Reactions Reported in ≥5% of Patients During the Open-Label Titration Period and Double-Blind Treatment Period by Preferred Term — Number (%) of Treated Patients (12-Week Study In Opioid-Naïve Patients with Low Back Pain) Open-Label Titration Period Double-Blind Treatment Period Oxymorphone Hydrochloride Extended-Release Tablets Oxymorphone Hydrochloride Extended-Release Tablets Placebo Preferred Term (N = 325) (N = 105) (N = 100) Constipation 26% 7% 1% Somnolence 19% 2% 0% Nausea 18% 11% 9% Dizziness 11% 5% 3% Headache 11% 4% 2% Pruritus 7% 3% 1% Table 3: Treatment-Emergent Adverse Reactions Reported in ≥5% of Patients During the Open-Label Titration Period and Double-Blind Treatment Period by Preferred Term — Number (%) of Treated Patients (12-Week Study In Opioid-Experienced Patients with Low Back Pain) Open-Label Titration Period Double-Blind Treatment Period Oxymorphone Hydrochloride Extended-Release Tablets Oxymorphone Hydrochloride Extended-Release Tablets Placebo Preferred Term (N = 250) (N = 70) (N = 72) Nausea 20% 3% 1% Constipation 12% 6% 1% Headache 12% 3% 0% Somnolence 11% 3% 0% Vomiting 9% 0% 1% Pruritus 8% 0% 0% Dizziness 6% 0% 0% The Table 4 lists adverse reactions that were reported in at least 2% of patients in placebo-controlled trials (N=5).

Table 4: Adverse Reactions Reported in Placebo-Controlled Clinical Trials with Incidence ≥2% in Patients Receiving Oxymorphone Hydrochloride Extended-Release Tablets MedDRA Preferred Term Oxymorphone Hydrochloride Extended-Release Tablets (N=1,259) Placebo (N=461) Nausea 33% 13% Constipation 28% 13% Dizziness (Excl Vertigo) 18% 8% Somnolence 17% 2% Vomiting 16% 4% Pruritus 15% 8% Headache 12% 6% Sweating increased 9% 9% Dry mouth 6% < 1% Sedation 6% 8% Diarrhea 4% 6% Insomnia 4% 2% Fatigue 4% 1% Appetite dec…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 5 includes clinically significant drug interactions with Oxymorphone Hydrochloride Extended-Release Tablets. Table 5: Clinically Significant Drug Interactions with Oxymorphone Hydrochloride Extended-Release Tablets Alcohol Clinical Impact: The concomitant use of alcohol with Oxymorphone Hydrochloride Extended-Release Tablets can result in an increase of oxymorphone plasma levels and potentially fatal overdose of oxymorphone. Intervention: Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products containing alcohol while on Oxymorphone Hydrochloride Extended-Release Tablets therapy [see Clinical Pharmacology (12.3) ].

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.

Inform patients and caregivers of this potential interaction, educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration (2.2) and Warnings and Precautions (5.1 , 5.2 , 5.3) ]. 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, frequently evaluate the patient, particularly during treatment initiation and dose adjustment. Discontinue Oxymorphone Hydrochloride Extended-Release Tablets if serotonin syndrome is suspected.

Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.3) ].

Intervention: The use of Oxymorphone Hydrochloride Extended-Release Tablets are not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Examples: phenelzine, tranylcypromine, linezolid Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics Clinical Impact: May reduce the analgesic effect of Oxymorphone Hydrochloride Extended-Release Tablets and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use.

Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Intervention: Evaluate patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. Muscle Relaxants Clinical Impact: Oxymorphone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Intervention: Because respiratory depression may be greater than otherwise expected, decrease the dosage of Oxymorphone Hydrochloride Extended-Release Tablets and/or the muscle relaxant as necessary. Due…

👥 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 Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4) ] . Available data with Oxymorphone Hydrochloride Extended-Release Tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, reduced postnatal survival of pups and an increased incidence of stillborn pups were observed following oral treatment of pregnant rats with oxymorphone during gestation and through lactation at doses 2.4 and 12 times the human daily dose of 20 mg/day (HDD), respectively.

Reduced fetal weights were observed with oral administration of oxymorphone to pregnant rats and rabbits during organogenesis at exposures up to 4.9 and 48.8 times the HDD, respectively [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 clinical recognized pregnancies is 2% to 4% and 14% to 20%, respectively. Clinical Considerations Fetal/Neonatal adverse reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes may cause fetal-neonatal physical dependence and neonatal 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. Oxymorphone Hydrochloride Extended-Release Tablets are not recommended for use in women during and immediately prior to labor, when use of shorter acting analgesics or other analgesic techniques are more appropriate.

Opioid analgesics, including Oxymorphone Hydrochloride 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 oxymorphone hydrochloride from Gestation Day 6 to 17 via oral gavage doses of 5 mg/kg/day, 10 mg/kg/day or 25 mg/kg/day (2.4, 4.9, or 12.2 times the HDD based on body surface area, respectively). Reduced mean fetal weights were observed at 4.9 times the HDD. Maternal toxicity was noted in all treatment groups (reduced food consumption and body weights in all groups and mortality in the high dose group).

Pregnant rabbits were treated with oxymorphone hydrochloride from Gestation Day 7 to 20 via oral gavage doses of 10 mg/kg/day, 25 mg/kg/day or 50 mg/kg/day (9.8, 24.4, or 48.8 times the HDD based on body surface area, respectively). Decreased mean fetal weights were noted at 48.8 times the HDD. Maternal toxicity was noted in all treatment groups (reduced food consumption and body weights).

P…

🤰 Pregnancy ~3 min read ▾

Pregnant rats were treated with oxymorphone hydrochloride from Gestation Day 6 to Lactation Day 20 via oral…

🧒 Pediatric Use 86 words ▾

8.4Pediatric Use The safety and effectiveness of Oxymorphone Hydrochloride Extended-Release Tablets in patients below the age of 18 years have not been established. Two open-label studies were conducted in a total of 42 pediatric patients between the ages of 7 to 17 years requiring continuous, around the clock opioid treatment. The available safety and efficacy data were inconclusive for chronic use of Oxymorphone Hydrochloride Extended-Release Tablets.

Limited data from one of the studies suggested that Oxymorphone Hydrochloride Extended-Release Tablets is not recommended for post-surgical pain.

🧓 Geriatric Use 217 words ▾

8.5Geriatric Use Of the total number of subjects in clinical studies of Oxymorphone Hydrochloride Extended-Release Tablets, 27% were 65 and over, while 9% were 75 and over. No overall differences in effectiveness were observed between these subjects and younger subjects. There were several adverse events that were more frequently observed in subjects 65 and over compared to younger subjects.

These adverse events included dizziness, somnolence, confusion and nausea. On average, age greater than 65 years was associated with an increase in oxymorphone AUC and C max . Initiate dosing with Oxymorphone Hydrochloride Extended-Release Tablets in patients 65 years of age and over using the 5 mg dose and frequently reevaluate the patient for signs of respiratory and central nervous system depression when initiating and titrating Oxymorphone Hydrochloride Extended-Release Tablets [see Warnings and Precautions (5.2) ] .

For patients on prior opioid therapy, start at 50% of the starting dose for a younger patient on prior opioids and titrate slowly. Oxymorphone 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 the elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Clinical Presentation Acute overdosage with Oxymorphone Hydrochloride 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 completed airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with severe hypoxia in overdose situations [see Clinical Pharmacology (12.2) ] .

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 measures.

Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist. Because the duration of opioid reversal is expected to be less than the duration of action of oxymorphone in Oxymorphone Hydrochloride Extended-Release Tablets, carefully monitor the patient until spontaneous respiration is reliably re-established.

Oxymorphone Hydrochloride Extended-Release Tablets will continue to release oxymorphone and add to the oxymorphone load for 24 to 48 hours or longer following ingestion, necessitating prolonged monitoring. If the response to opioid antagonists is suboptimal or only brief in nature, administer additional antagonists as directed by 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 Oxymorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxymorphone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxymorphone.

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 CNS Depressant/Alcohol Interaction Additive pharmacodynamic effects may be expected when Oxymorphone Hydrochloride Extended-Release Tablets are used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Effects on the Central Nervous System Oxymorphone 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 carbon dioxide tension and electrical stimulation.

Oxymorphone 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.

Effects on the Gastrointestinal Tract and on Other Smooth Muscle Oxymorphone 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 is 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 Oxymorphone produces peripheral vasodilation which may result in orthostatic hypotension or syncope. Release of histamine can occur and may contribute to opioid-induced hypotension.

Manifestations of histamine release and/ or peripheral vasodilation may include pruritis, 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.

Use of opioids for an extended period of time 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 The minimum effective plasma concentration of oxymorphone varies widely among patients, especially among patients who have been previously treated with opioid agonists. The minimum effective analgesic concentration of oxymorphone for any…

🧬 Mechanism of Action 114 words ▾

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied as follows: 5 mg Purple, round, film-coated extended-release tablets debossed with "G71" on one side and blank on the other side. Bottles of 30 NDC 0115-1231-08 Bottles of 60 NDC 0115-1231-13 Bottles of 100 NDC 0115-1231-01 Bottles of 1,000 NDC 0115-1231-03 7.5 mg Gray, round, film-coated extended-release tablets debossed with "G75" on one side and blank on the other side. Bottles of 30 NDC 0115-1315-08 Bottles of 60 NDC 0115-1315-13 Bottles of 100 NDC 0115-1315-01 Bottles of 1,000 NDC 0115-1315-03 10 mg Orange, round, film-coated extended-release tablets debossed with "G72" on one side and blank on the other side.

Bottles of 30 NDC 0115-1232-08 Bottles of 60 NDC 0115-1232-13 Bottles of 100 NDC 0115-1232-01 Bottles of 1,000 NDC 0115-1232-03 15 mg White, round, film-coated extended-release tablets debossed with "G76" on one side and blank on the other side. Bottles of 30 NDC 0115-1316-08 Bottles of 60 NDC 0115-1316-13 Bottles of 100 NDC 0115-1316-01 Bottles of 1,000 NDC 0115-1316-03 20 mg Green, round, film-coated extended-release tablets debossed with "G73" on one side and blank on the other side. Bottles of 30 NDC 0115-1233-08 Bottles of 60 NDC 0115-1233-13 Bottles of 100 NDC 0115-1233-01 Bottles of 1,000 NDC 0115-1233-03 30 mg Brown, round, film-coated extended-release tablets debossed with "G77" on one side and blank on the other side.

Bottles of 30 NDC 0115-1317-08 Bottles of 60 NDC 0115-1317-13 Bottles of 100 NDC 0115-1317-01 Bottles of 1,000 NDC 0115-1317-03 40 mg Orange, round, film-coated extended-release tablets debossed with "G74" on one side and blank on the other side. Bottles of 30 NDC 0115-1234-08 Bottles of 60 NDC 0115-1234-13 Bottles of 100 NDC 0115-1234-01 Bottles of 1,000 NDC 0115-1234-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required).

Store Oxymorphone Hydrochloride Extended-Release Tablets securely and dispose of properly [see Patient Counseling Information (17) ] .

📋 Description ~1 min read ▾

11 DESCRIPTION Oxymorphone Hydrochloride Extended-Release Tablets, USP are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet.

The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose, xanthan gum, magnesium stearate, polyvinyl alcohol - partially hydrolyzed, polyethylene glycol, talc, and titanium dioxide. The 5 mg, 7.5 mg, 10 mg, 20 mg and 40 mg tablets contain FD&C Yellow No. 6 Aluminum Lake.

In addition, the 5 mg tablets contain FD&C Blue No. 2 and D&C Red No. 27.

The 7.5 mg tablets contain FD&C Blue No. 2 and FD&C Red No. 40.

The 10 mg tablets contain FD&C Red No. 40. The 20 mg tablets contain D&C Yellow No.

10 Aluminum Lake, FD&C Blue No. 1, and FD&C Blue No. 2.

The 30 mg tablets contain Iron Oxide Yellow and Iron Oxide Black. The 40 mg tablets contain D&C Yellow No. 10 Aluminum Lake.

The chemical name of oxymorphone hydrochloride is 4,5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. Oxymorphone hydrochloride, USP is a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80.

The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows: Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal Because of the risks associated with accidental ingestion, misuse and abuse, advise patients to store Oxymorphone Hydrochloride Extended-Release Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving Oxymorphone Hydrochloride Extended-Release Tablets unsecured can pose a deadly risk to others in the home [see Warnings and Precautions (5.1 , 5.3 ) and Drug Abuse and Dependence (9.2) ] .

Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused Oxymorphone Hydrochloride Extended-Release Tablets should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.

Addiction, Abuse, and Misuse Inform patients that the use of Oxymorphone Hydrochloride Extended-Release Tablets, even when taken as recommended, can result in addiction, abuse and misuse, which can lead to overdose or death [see Warnings and Precautions (5.1) ] . Instruct patients not to share Oxymorphone Hydrochloride Extended-Release Tablets with others and to take steps to protect Oxymorphone Hydrochloride 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 Oxymorphone Hydrochloride Extended-Release Tablets or when the dosage is increased, and that it can occur even at recommended doses.

Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions (5.3) ] . Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.2) ] . Interactions with Benzodiazepines and other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Oxymorphone Hydrochloride Extended-Release Tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider [see Warnings and Precautions (5.3) and Drug Interactions (7) ].

Instruct patients not to consume alcoholic beverages, as well as prescription and over-the-counter products that contain alcohol, during treatment with Oxymorphone Hydrochloride Extended-Release Tablets. The co-ingestion of alcohol with Oxymorphone Hydrochloride Extended-Release Tablets may result in increased plasma levels and a potentially fatal overdose of oxymorphone [see Warnings and Precautions (5.5) ] . Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with Oxymorphone Hydrochloride Extended-Release Tablets.

Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) [see Dosage and Administration (2.2) and Warnings and Precautions (5.3) ] . Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emergency…

💬 Medication Guide ~3 min read ▾

Medication Guide Oxymorphone Hydrochloride (ox” i mor’ fone hy” droe klor’ ide) Extended-Release Tablets, USP for oral use, CII Oxymorphone Hydrochloride Extended-Release Tablets are: A strong prescription pain medicine that contains and opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine, when other pain 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 to be taken on an “as needed” basis. Important information about Oxymorphone Hydrochloride Extended-Release Tablets: Get emergency help or call 911 right away if you take too much Oxymorphone Hydrochloride Extended-Release Tablets (overdose).

When you first start taking Oxymorphone Hydrochloride 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. Taking Oxymorphone Hydrochloride 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 Oxymorphone Hydrochloride Extended-Release Tablets. They could die from taking it. Selling or giving away Oxymorphone Hydrochloride Extended-Release Tablets is against the law.

Store Oxymorphone Hydrochloride Extended-Release Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take Oxymorphone Hydrochloride Extended-Release Tablets if you have: severe asthma, trouble breathing, or other lung problems. a bowel blockage or have a narrowing of the stomach or intestines. Before taking Oxymorphone Hydrochloride Extended-Release Tablets, tell your healthcare provider if you have a history of: head injury, seizures problems urinating abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems liver, kidney, thyroid problems pancreas or gallbladder problems Tell your healthcare provider if you are: noticing your pain getting worse.

If your pain gets worse after you take Oxymorphone Hydrochloride Extended-Release Tablets, do not take more of Oxymorphone Hydrochloride Extended-Release Tablets without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking Oxymorphone Hydrochloride Extended-Release Tablets. pregnant or planning to become pregnant. Use of Oxymorphone Hydrochloride Extended-Release Tablets for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. breast-feeding.

Not recommended during treatment with Oxymorphone Hydrochloride Extended-Release Tablets. It may harm your baby. living in a household where there are small children or someone who has abused street or prescription drugs. taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Oxymorphone Hydrochloride Extended-Release Tablets with certain other medicines can cause serious side effects that could lead to death.

When taking Oxymorphone Hydrochloride Extended-Release Tablets: Do not change your dose. Take Oxymorphone Hydrochloride 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 ever…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

immunosuppressive: Describes something that lowers the activity of the immune system.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

abuse: Using a medicine in a way it was not meant to be used, such as taking more than prescribed to feel a high.

adrenal insufficiency: A condition where the adrenal glands do not make enough of certain needed hormones, such as cortisol, a stress hormone.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

amenorrhea: The absence of monthly menstrual periods.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

controlled substance: A medicine regulated by law because it can be misused or lead to dependence, with special rules for prescribing and storage.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dosage form: The physical form a medicine comes in, such as a tablet, capsule, liquid, patch, or injection.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Abuse and Dependence: A label section describing a medicine's potential to be misused and to cause the body to rely on it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erectile dysfunction: Trouble getting or keeping an erection.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

hypoxia: A condition in which the body's tissues do not get enough oxygen.

ileus: A slowdown or stop in the normal movement of the intestines, so food and waste do not pass through.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

misuse: Using a medicine differently from how it was prescribed or directed, whether on purpose or by mistake.

mydriasis: Widening of the pupil, the dark center of the eye.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

orthostatic hypotension: A drop in blood pressure when you stand up from sitting or lying down, which can cause brief dizziness.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

partial agonist: A substance that switches on a body target only part way, giving a weaker effect than a full activator would.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

physical dependence: When the body adapts to a medicine over time, so stopping it suddenly causes uncomfortable symptoms.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

PRN: Taken only as needed rather than on a fixed schedule; from the Latin phrase meaning "as the situation arises.".

pruritus: Itching of the skin.

pulmonary edema: A buildup of fluid in the lungs' air sacs that makes it hard to breathe.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

REMS: A special FDA-required safety program that manages a serious risk, sometimes adding extra steps for patients, pharmacists, or prescribers.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vasodilation: Widening of blood vessels, which lets more blood flow through and can lower blood pressure.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 00115-1232-01 · Amneal 00115-1234-01 · Amneal →

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.

Oxymorphone hydrochloride 20 mg Tablet, Film Coated, Extended Release, 1,000-count

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