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Oxycodone Hydrochloride

Prescription ANDA Schedule CII TE AA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Oxycodone Hydrochloride
Generic name
Oxycodone Hydrochloride
Dosage form
Solution
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Bryant Ranch Prepack
Product type
Human Prescription Drug
DEA schedule
CII
Active ingredients
3
NDC product codes
23
Packages
33
Data completeness
83% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Oxycodone Hydrochloride 100 mg/5mL 1049621 View
Oxycodone Hydrochloride 20 mg/mL 1049621 View
Oxycodone Hydrochloride 5 mg/5mL 1049621 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Oral
Presentations
56

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Full Opioid Agonists [MoA] MoA All 74 members
Opioid Agonist [EPC] EPC All 109 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
207511
Application type
ANDA · Abbreviated New Drug Application
Approval date
November 23, 2016
Sponsor
HIBROW HLTHCARE
Products on application
1
Submissions recorded
13
Products approved under application 207511.
Product Trade name Form Strength Ingredient Status TE Flags
207511-001 OXYCODONE HYDROCHLORIDE SOLUTION OXYCODONE HYDROCHLORIDE Prescription AA

Therapeutic equivalence

Source: Orange Book
TE code
AA
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — no known or suspected bioequivalence problems (conventional dosage forms)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 207511.
Type No. Action Status Date Review
Supplement 15 REMS Approved June 18, 2026 —
Supplement 14 Labeling Approved December 29, 2025 Standard
Supplement 13 Labeling Approved December 5, 2025 Standard
Supplement 11 Labeling Approved December 5, 2025 Standard
Supplement 10 Labeling Approved December 5, 2025 Standard
Supplement 8 Labeling Approved December 5, 2025 Standard
Supplement 5 Labeling Approved December 5, 2025 Standard
Supplement 4 Labeling Approved December 5, 2025 Standard
Supplement 12 REMS Approved October 31, 2024 —
Supplement 7 Manufacturing (CMC) Approved March 20, 2020 Unknown
Supplement 3 REMS Approved September 18, 2018 —
Supplement 2 Manufacturing (CMC) Approved June 22, 2018 Unknown
Original application 1 Approved November 23, 2016 Standard

Review documents

  • 0 · Original application · November 3, 2023

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260729). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20260729 HUMAN PRESCRIPTION DRUG · 20260616 HUMAN PRESCRIPTION DRUG · 20260212 HUMAN PRESCRIPTION DRUG · 20260202

Boxed Warning

openFDA Drug Labeling

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 Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Oxycodone Hydrochloride Oral Solution. Dosing errors due to confusion between mg and mL, and other oxycodone hydrochloride oral solutions of different concentrations can result in accidental overdose. [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ] . Addiction, Abuse, and Misuse Oxycodone Hydrochloride Oral Solution exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk prior to prescribing Oxycodone Hydrochloride Oral Solution, and monitor all patients regularly for the development of these behaviors and conditions. [see Warnings and Precautions (5.2) ]. 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 (5.3) ] . 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 Hydrochloride Oral Solution. Monitor for respiratory depression, especially during initiation of Oxycodone Hydrochloride Oral Solution or following a dose increase. [see Warnings and Precautions (5.4) ] . Accidental Ingestion Accidental ingestion of even one dose of Oxycodone Hydrochloride Oral Solution, especially by children, can result in a fatal overdose of oxycodone. [see Warnings and Precautions(5.4) ] . Neonatal Opioid Withdrawal Syndrome Prolonged use of Oxycodone Hydrochloride Oral Solution 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 (5.5) ] . Cytochrome P450 3A4 Interaction The concomitant use of Oxycodone Hydrochloride Oral Solution with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions 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 Hydrochloride Oral Solution and any CYP3A4 inhibitor or inducer. [see Warnings and Precautions (5.6) , 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 (5.7) , Drug Interactions (7) ] . Reserve concomitan …

Recent Major Changes

openFDA Drug Labeling

Boxed Warning 11/2025 Indications and Usage ( 1 ) 11/2025 Dosage and Administration ( 2.2 , 2.5 ) 11/2025 o 2.2 Patient Access to an Opioid Overdose Reversal Agent For the Emergency Treatment of Opioid Overdose o 2.5 Safe Reduction or Discontinuation of oxycodone hydrochloride Warnings and Precautions ( 5.2 , 5.3 , 5.4 , 5.6 , 5.13 , 5.15 ) 11/2025 o 5.2 Addiction, Abuse and Misuse o 5.3 Life-Threatening Respiratory Depression o 5.4 Risk from Concomitant Use with Benzodiazepines or Other CNS Depressants o 5.6 Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) o 5.13 Risk of Gastrointestinal Complications o 5.15 Withdrawal Adverse Reactions 11/2025 Use in Specific Populations ( 8.1 ) 11/2025 o Pregnancy Drug Abuse And Dependence ( 9.3 ) 11/2025 o Dependence Overdosage 11/2025 Clinical Pharmacology ( 12.2 ) 11/2025 o Pharmacodynamics Patient Counseling Information 11/2025

Indications and Usage

openFDA Drug Labeling

1 INDICATIONS AND USAGE Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults. Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults. Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.2 ), reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia Oxycodone Hydrochloride Oral Solution should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.2) ] , reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated or are not expected to be tolerated Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone Hydrochloride Oral Solution should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Dosage and Administration

openFDA Drug Labeling

2 DOSAGE AND ADMINISTRATION • Oxycodone Hydrochloride Oral Solution should be prescribed only by healthcare professionals who are knowledgeable about the use of 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 Oxycodone Hydrochloride Oral Solution 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 ) • Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) • 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 , 5.2 ) • Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Oxycodone Hydrochloride Oral Solution. Consider this risk when selecting an initial dose and making dose adjustments. ( 2.1 , 5.3 ) • 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 Oxycodone Hydrochloride Oral Solution. Consider prescribing naloxone based on the patient’s risk factors for overdose. ( 2.2 , 5.2 , 5.3 , 5.4 ) • Initiate dosing with a range of 5 to 15 mg every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of Oxycodone Hydrochloride Oral Solution. ( 2.2 , 2.4 ) • Do not abruptly discontinue Oxycodone Hydrochloride Oral Solution 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 ) 2.1 Important Dosage and Administration Instructions Ensure accuracy when prescribing, dispensing, and administering Oxycodone Hydrochloride Oral Solution to avoid dosing errors due to confusion between mg and mL, and with other oxycodone hydrochloride solutions of different concentrations, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Instruct patients and caregivers on how to accurately measure and take or administer the correct dose of Oxycodone Hydrochloride Oral Solution. Strongly advise patients and caregivers to always use the enclosed graduated measuring cup when administering Oxycodone Hydrochloride Oral Solution 5 mg/5 mL (1 mg/mL) to ensure that the dose is measured and administered accurately. Instruct patients and caregivers to never use household teaspoons or tablespoons to measure Oxycodone Hydrochloride Oral Solution. • Oxycodone Hydrochloride Oral Solution should be prescribed only by healthcare professionals who are knowledgeable about the use of 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 Oxycodone Hydrochloride Oral Solution 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. • Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) …

Dosage Forms and Strengths

openFDA Drug Labeling

3 DOSAGE FORMS AND STRENGTHS Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL) Strength Oral Solution: Each 5 mL of clear colorless Oxycodone Hydrochloride Oral Solution, USP contains oxycodone hydrochloride 5 mg. 100 mg per 5 mL (20 mg per mL) Strength Oral Solution: Each 5 mL of light orange Oxycodone Hydrochloride Oral Solution, USP contains oxycodone hydrochloride 100 mg. Oral Solution 5 mg per 5 mL (1 mg/mL) 100 mg per 5 mL (20 mg/ mL): (3)

Contraindications

openFDA Drug Labeling

4 CONTRAINDICATIONS Oxycodone Hydrochloride Oral Solution is 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 ( 5.9 )] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.13 )] • Hypersensitivity to oxycodone (e.g., angioedema) [Adverse Reactions ( 6 )] • 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

openFDA Drug Labeling

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. ( 5.8 ) L ife-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate, particularly during initiation and titration. ( 5.9 ) A d r e n al Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.10 ) S e v e r e Hypotension : Regularly evaluate during dosage initiation and titration. Avoid use of Oxycodone Hydrochloride Oral Solution 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 Oxycodone Hydrochloride Oral Solution in patients with impaired consciousness or coma. ( 5.12 ) 5.1 Risk of Accidental Overdose and Death Due to Medication Errors Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion with oxycodone solutions of different concentrations, when prescribing, dispensing, and administering Oxycodone Hydrochloride Oral Solution. Ensure that the dose is communicated clearly and dispensed accurately. Instruct patients and caregivers on how to measure and take or administer the correct dose of Oxycodone Hydrochloride Oral Solution and to use extreme caution when measuring the dose. Instruct patients and caregivers to always use the enclosed graduated measuring cup when administering Oxycodone Hydrochloride Oral Solution to ensure the dose is measured and administered accurately. Instruct them to never use a teaspoon or a tablespoon to measure a dose because household teaspoons or tablespoons are not an adequate measuring device. 5.2 Addiction, Abuse, and Misuse Oxycodone Hydrochloride Oral Solution contains oxycodone, a Schedule II controlled substance. As an opioid, Oxycodone Hydrochloride Oral Solution exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9 ) ]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Oxycodone Hydrochloride Oral Solution. Addiction can occur at recommended doses and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see Adverse Reactions ( 6 ) ]. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Oxycodone Hydrochloride Oral Solution, and reassess all patients receiving Oxycodone Hydrochloride Oral Solution 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 Hydrochloride Oral Solution, but use in such patients necessitates intensive counseling about the risks and proper use of oxycodone hydrochloride along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration ( 2.2 ), Warnings and Precautions (5.3 ) ]. Opioids are sought for non-medical use and are subject to diver …

Adverse Reactions

openFDA Drug Labeling

6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.2 )] • Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.3 )] • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions ( 5.4 )] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.5 )] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.8 )] • Adrenal Insufficiency [see Warnings and Precautions ( 5.10 )] • 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 )] The following adverse reactions associated with the use of oxycodone were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adverse reactions associated with oxycodone use included: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock. The common adverse reactions seen on initiation of therapy with oxycodone are dose-related and are typical opioid-related adverse reactions. The most frequent adverse events include nausea, constipation, vomiting, headache, and pruritus. The frequency of these reactions depended on several factors, including clinical setting, the patient's level of opioid tolerance, and host factors specific to the individual. In all patients for whom dosing information was available (n = 191) from the open-label and double-blind studies involving another formulation of immediate-release oxycodone, the following adverse events were recorded in oxycodone treated patients with an incidence ≥ 3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. The other less frequently observed adverse reactions from opioid analgesics, including Oxycodone Hydrochloride Oral Solution included: Body as a Whole: abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis. Cardiovascular: deep thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia. Digestive: anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting. Hemic and Lymphatic: anemia and leukopenia. Metabolic and Nutritional: edema, gout, hyperglycemia, iron deficiency anemia and peripheral edema. Musculoskeletal: arthralgia, arthritis, bone pain, myalgia and pathological fracture. Nervous: agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation. Respiratory: bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis. Skin and Appendages: herpes simplex, rash, sweating, and urticaria. Special Senses: amblyopia. Urogenital: urinary tract infection. Serotonin Syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Adrenal Insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Anaphylaxis: Anaphylaxis has been reported with ingredients contained in Oxycodone Hydrochloride Oral Solution. Androgen Deficiency: Cases of androgen deficiency have occurred with use of opioids for an extended time [see Clinical Pharmacology ( 12.2 )] . Hyperalgesia and Allodynia: Cases of hyperalgesia and allodyn …

Drug Interactions

openFDA Drug Labeling

7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with Oxycodone Hydrochloride Oral Solution. Table 1: Clinically Significant Drug Interactions with Oxycodone Hydrochloride Oral Solution Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of Oxycodone Hydrochloride Oral Solution 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 Hydrochloride Oral Solution and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Oxycodone Hydrochloride Oral Solution is achieved [see Warnings and Precautions ( 5.7 )] . 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 Hydrochloride Oral Solution until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the Oxycodone Hydrochloride Oral Solution dosage until stable drug effects are achieved [see Dosage and Administration ( 2.3 )] . Evaluate 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 Hydrochloride Oral Solution 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 ( 5.15 )] . 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 Hydrochloride Oral Solution dosage until stable drug effects are achieved. Evaluate patients for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Oxycodone Hydrochloride Oral Solution dosage reduction and evaluate patients at frequent intervals for signs of respiratory depression and sedation. 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. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.2 , 5.3 , 5.4 )] . Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), 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 [see Warnings and Precautions ( 5.10 )] …

Use in Specific Populations

openFDA Drug Labeling

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 ) 8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.5 )] . Available data with Oxycodone Hydrochloride Oral Solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity. In several published studies, treatment of pregnant rats with oxycodone 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 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 Use of opioid analgesics for an extended period of time 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 ( 5.5 )] . 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 Hydrochloride Oral Solution is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Oxycodone Hydrochloride Oral Solution, 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 dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of oxycodone hydrochloride administered during the period of organogenesis up to 16 mg/kg/day and up to 25 mg/kg/day, respectively. These studies revealed no evidence of teratogenicity or embryo-fetal toxicity due to oxycodone. The highest doses tested in rats and rabbits were equivalent to approximately 2.6 and 8.1 times an adult human dose of 60 mg/day, respectively, on a mg/m 2 basis. In published studies, offspring of pregnant rats administered oxycodone during gestation have been reported to exhibit neurobehavioral effects including altered stress responses, increased anxiety-like behavior (2 mg/kg/day IV from Gestation Day 8 to 21 and Postnatal Day 1, 3, and 5; 0.3-times an adult human dose of 60 mg/day, on a mg/m 2 basis) and altered learning and memory (15 mg/kg/day orally from breeding through parturition; 2.4 times an adult human dose of 60 mg/day, on a mg/m 2 basis). 8.2 Lactation Risk Summ …

Mechanism of Action

openFDA Drug Labeling

12.1 Mechanism of Action oxycodone 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 oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with 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.

Description

openFDA Drug Labeling

11 DESCRIPTION Oxycodone Hydrochloride Oral Solution, USP is an agonist, available as a red solution 5 mg/5 mL (1 mg/mL) and a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18 H 21 NO 4 • HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL) include: FD&C Red #40 powder, glycerin, hydrochloric acid, maltitol syrup, natural/artificial berry flavor, purified water, sodium benzoate, sorbitol, and sucralose powder. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, USP 100 mg per 5 mL (20 mg/ mL) include: D&C Yellow #10, glycerin, hydrochloric acid, maltitol syrup, natural/artificial berry flavor, purified water, sodium benzoate, sorbitol, and sucralose powder. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. figure-01-chemical-structure

10 OVERDOSAGE Clinical Presentation Acute overdose with Oxycodone Hydrochloride Oral Solution 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 [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 and 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 opioid reversal is expected to be less than the duration of action of oxycodone in Oxycodone Hydrochloride Oral Solution, carefully monitor the patient until spontaneous respiration is reliably re-established. 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.

How Supplied / Storage and Handling

openFDA Drug Labeling

16 HOW SUPPLIED/STORAGE AND HANDLING Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL (1 mg/mL), is a red solution, supplied as: NDC# 64950-354-10: Bottle of 100 mL supplied with a calibrated measuring cup NDC# 64950-354-50: Bottle of 500 mL supplied with a calibrated measuring cup NDC# 64950-354-05: 5 mL unit dose cup NDC# 64950-354-45: Case contains 40 unit dose cups of 5 mL (NDC 64950-354-05), packaged in 4 trays of 10 unit dose cups each NDC# 64950-354-55: Case contains 50 unit dose cups of 5 mL (NDC 64950-354-05), packaged in 5 trays of 10 unit dose cups each Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL), is a yellow solution, supplied as: NDC# 64950-353-03: Bottle of 30 mL supplied with a calibrated oral syringe NDC# 64950-353-01: Prefilled Oral Dispenser, 10 mg per 0.5 mL NDC# 64950-353-02: Prefilled Oral Dispenser, 20 mg per mL NDC# 64950-353-51: Case contains 50 prefilled oral dispensers of 10 mg/0.5 mL (NDC # 64950-353-01), packaged in 10 pouches of 5 prefilled oral dispensers each (NDC# 64950-353-91) NDC# 64950-353-52: Case contains 50 prefilled oral dispensers of 20 mg/mL (NDC# 64950-353-02), packaged in 10 pouches of 5 prefilled oral dispensers each (NDC# 64950-353-92) Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° - 30°C (59° - 86°F). PROTECT from MOISTURE and LIGHT. Store Oxycodone Hydrochloride Oral Solution securely and dispose of properly .

Adverse event reports

Source: openFDA FAERS
283,373
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: OXYCODONE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class II March 16, 2022 American Health Packaging Impurity failure at 0-time of the repackaged lot. Terminated
Class III January 20, 2021 Genus Lifesciences Inc. Presence of Foreign Substance: Particulate matter was found in multiple lots of product. Terminated
Class III July 20, 2016 West-Ward Columbus Inc Failed Impurities/Degradation Specification; 9 month stability Terminated

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
62559-151-16 62559-151 ANI Pharmaceuticals, Inc. 1 BOTTLE in 1 CARTON (62559-151-16) / 473 mL in 1 BOTTLE October 13, 2015
60687-406-67 60687-406 American Health Packaging 5 TRAY in 1 CASE (60687-406-67) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-406-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-406-40) April 22, 2019
60687-406-77 60687-406 American Health Packaging 4 TRAY in 1 CASE (60687-406-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-406-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-406-40) April 22, 2019
43602-190-31 43602-190 Ascent Pharmaceuticals Inc 30 mL in 1 BOTTLE (43602-190-31) July 13, 2017
43602-190-50 43602-190 Ascent Pharmaceuticals Inc 500 mL in 1 BOTTLE (43602-190-50) July 13, 2017
43602-198-31 43602-198 Ascent Pharmaceuticals Inc 30 mL in 1 BOTTLE (43602-198-31) July 13, 2017
43602-198-50 43602-198 Ascent Pharmaceuticals Inc 500 mL in 1 BOTTLE (43602-198-50) July 13, 2017
63629-1174-1 63629-1174 Bryant Ranch Prepack 1 BOTTLE in 1 CARTON (63629-1174-1) / 473 mL in 1 BOTTLE March 1, 2019
63629-2104-1 63629-2104 Bryant Ranch Prepack 473 mL in 1 BOTTLE (63629-2104-1) October 13, 2015
72162-1749-2 72162-1749 Bryant Ranch Prepack 1 BOTTLE in 1 CARTON (72162-1749-2) / 473 mL in 1 BOTTLE October 13, 2015
71930-022-43 71930-022 Eywa Pharma Inc 1 BOTTLE in 1 CARTON (71930-022-43) / 473 mL in 1 BOTTLE March 1, 2019
71930-023-30 71930-023 Eywa Pharma Inc 1 BOTTLE in 1 CARTON (71930-023-30) / 30 mL in 1 BOTTLE June 1, 2018
64950-354-10 64950-354 Genus Lifesciences Inc. 1 BOTTLE, PLASTIC in 1 CARTON (64950-354-10) / 100 mL in 1 BOTTLE, PLASTIC September 9, 2013
64950-354-45 64950-354 Genus Lifesciences Inc. 40 CUP, UNIT-DOSE in 1 CASE (64950-354-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05) September 9, 2013
64950-354-50 64950-354 Genus Lifesciences Inc. 1 BOTTLE, PLASTIC in 1 CARTON (64950-354-50) / 500 mL in 1 BOTTLE, PLASTIC September 9, 2013
64950-354-55 64950-354 Genus Lifesciences Inc. 50 CUP, UNIT-DOSE in 1 CASE (64950-354-55) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05) September 9, 2013
0054-0390-63 0054-0390 Hikma Pharmceuticals USA Inc. 500 mL in 1 BOTTLE (0054-0390-63) September 4, 2014
10702-171-03 10702-171 KVK-Tech, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (10702-171-03) / 30 mL in 1 BOTTLE, PLASTIC July 21, 2017
10702-183-50 10702-183 KVK-Tech, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (10702-183-50) / 500 mL in 1 BOTTLE, PLASTIC July 21, 2017
43386-920-60 43386-920 Lupin Pharmaceuticals, Inc. 1 BOTTLE in 1 CARTON (43386-920-60) / 30 mL in 1 BOTTLE April 29, 2015
0904-6678-40 0904-6678 MAJOR PHARMACEUTICALS 1 BOTTLE, PLASTIC in 1 CARTON (0904-6678-40) / 500 mL in 1 BOTTLE, PLASTIC November 23, 2016
0904-6828-92 0904-6828 MAJOR PHARMACEUTICALS 5 TRAY in 1 CARTON (0904-6828-92) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-6828-05) November 23, 2016
0904-6828-94 0904-6828 MAJOR PHARMACEUTICALS 4 TRAY in 1 CARTON (0904-6828-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-6828-05) November 23, 2016
0121-0827-04 0121-0827 PAI Holdings, LLC dba PAI Pharma 118 mL in 1 BOTTLE (0121-0827-04) April 8, 2019
0121-0827-16 0121-0827 PAI Holdings, LLC dba PAI Pharma 500 mL in 1 BOTTLE (0121-0827-16) April 8, 2019
0121-4827-40 0121-4827 PAI Holdings, LLC dba PAI Pharma 4 TRAY in 1 CASE (0121-4827-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4827-05) April 10, 2019
0121-4827-50 0121-4827 PAI Holdings, LLC dba PAI Pharma 5 TRAY in 1 CASE (0121-4827-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4827-05) January 10, 2020
70752-136-10 70752-136 QUAGEN PHARMACEUTICALS LLC 1 BOTTLE, PLASTIC in 1 CARTON (70752-136-10) / 100 mL in 1 BOTTLE, PLASTIC June 2, 2021
70752-136-14 70752-136 QUAGEN PHARMACEUTICALS LLC 1 BOTTLE, PLASTIC in 1 CARTON (70752-136-14) / 500 mL in 1 BOTTLE, PLASTIC June 2, 2021
70752-137-03 70752-137 QUAGEN PHARMACEUTICALS LLC 1 BOTTLE in 1 CARTON (70752-137-03) / 30 mL in 1 BOTTLE June 2, 2021
67296-2167-6 67296-2167 Redpharm Drug 1 BOTTLE, PLASTIC in 1 CARTON (67296-2167-6) / 60 mL in 1 BOTTLE, PLASTIC September 9, 2013
0406-8556-05 0406-8556 SpecGx LLC 1 BOTTLE, PLASTIC in 1 CARTON (0406-8556-05) / 500 mL in 1 BOTTLE, PLASTIC April 30, 2018
0406-8557-30 0406-8557 SpecGx LLC 1 BOTTLE, PLASTIC in 1 CARTON (0406-8557-30) / 30 mL in 1 BOTTLE, PLASTIC April 30, 2018
62559-151 62559-151 ANI Pharmaceuticals, Inc. — October 13, 2015
60687-406 60687-406 American Health Packaging — April 22, 2019
43602-190 43602-190 Ascent Pharmaceuticals Inc — July 13, 2017
43602-198 43602-198 Ascent Pharmaceuticals Inc — July 13, 2017
63629-1174 63629-1174 Bryant Ranch Prepack — March 1, 2019
63629-2104 63629-2104 Bryant Ranch Prepack — October 13, 2015
72162-1749 72162-1749 Bryant Ranch Prepack — October 13, 2015
71930-022 71930-022 Eywa Pharma Inc — March 1, 2019
71930-023 71930-023 Eywa Pharma Inc — June 1, 2018
64950-354 64950-354 Genus Lifesciences Inc. — September 9, 2013
0054-0390 0054-0390 Hikma Pharmceuticals USA Inc. — September 4, 2014
10702-171 10702-171 KVK-Tech, Inc. — July 21, 2017
10702-183 10702-183 KVK-Tech, Inc. — July 21, 2017
43386-920 43386-920 Lupin Pharmaceuticals, Inc. — April 29, 2015
0904-6678 0904-6678 MAJOR PHARMACEUTICALS — November 23, 2016
0904-6828 0904-6828 MAJOR PHARMACEUTICALS — November 23, 2016
0121-0827 0121-0827 PAI Holdings, LLC dba PAI Pharma — April 8, 2019
0121-4827 0121-4827 PAI Holdings, LLC dba PAI Pharma — April 8, 2019
70752-136 70752-136 QUAGEN PHARMACEUTICALS LLC — June 2, 2021
70752-137 70752-137 QUAGEN PHARMACEUTICALS LLC — June 2, 2021
67296-2167 67296-2167 Redpharm Drug — September 9, 2013
0406-8556 0406-8556 SpecGx LLC — April 30, 2018
0406-8557 0406-8557 SpecGx LLC — April 30, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts
Enforcement FDA Recall records

Generated September 25, 2026 · 13 sections on this page.