Oxycodone Hydrochloride (Oxycodone Hydrochloride)

Trade Name : Oxycodone Hydrochloride

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED, EXTENDED RELEASE

Strength 10 mg/1

OXYCODONE HYDROCHLORIDE Full Opioid Agonists [MoA],Opioid Agonist [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Oxycodone Hydrochloride (Oxycodone Hydrochloride) which is also known as Oxycodone Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 10 mg/1 per ml. Read more

Oxycodone Hydrochloride (Oxycodone Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Arrayn- OXYCODONE HCl EXTENDED-RELEASE TABLETS exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing OXYCODONE HCl EXTENDED-RELEASE TABLETS and monitor all patients regularly for the development of these behaviors and conditions n
Arrayn- Arrayn- Array
Arrayn- Serious, life-threatening, or fatal respiratory depression may occur with use of OXYCODONE HCl EXTENDED-RELEASE TABLETS. Monitor for respiratory depression, especially during initiation of OXYCODONE HCl EXTENDED-RELEASE TABLETS or following a dose increase. Instruct patients to swallow OXYCODONE HCl EXTENDED-RELEASE TABLETS whole; crushing, chewing, or dissolving OXYCODONE HCl EXTENDED-RELEASE TABLETS can cause rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions ()].
Arrayn- Accidental ingestion of even one dose of OXYCODONE HCl EXTENDED-RELEASE TABLETS, especially by children, can result in a fatal overdose of oxycodone .
Arrayn- Prolonged use of OXYCODONE HCl EXTENDED-RELEASE TABLETS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .
Arrayn- The concomitant use of OXYCODONE HCl EXTENDED-RELEASE TABLETS with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving OXYCODONE HCl EXTENDED-RELEASE TABLETS and any CYP3A4 inhibitor or inducer .
Arrayn- Arrayn- Array
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 FROMCONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
u00a0
See full prescribing information for complete boxed warning.

OXYCODONE HCl EXTENDED-RELEASE TABLETS exposes users to risks of addiction, abuse and misuse, which can lead to overdose and death. Assess patientu2019s risk before prescribing and monitor regularly for these behaviors and conditions. ()
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow OXYCODONE HCl EXTENDED-RELEASE TABLETS whole to avoid exposure to a potentially fatal dose of oxycodone. ()
Accidental ingestion of OXYCODONE HCl EXTENDED-RELEASE TABLETS, especially by children, can result in a fatal overdose of oxycodone. ()
Prolonged use of OXYCODONE HCl EXTENDED-RELEASE TABLETS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. ()
Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone. (, , )
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 for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (, )

No data

OXYCODONE HCl EXTENDED-RELEASE TABLETS are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in:
Arrayn- Limitations of Use
OXYCODONE HCl EXTENDED-RELEASE TABLETS are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in:
Limitations of Use

Adults:
Pediatric Patients 11 Years of Age and Older
Geriatric Patients
Patients with Hepatic Impairment:

Extended-release tablets: 10 mg, 20 mg, 40 mg, and 80 mg
Extended-release tablets: 10 mg, 20 mg, 40 mg, and 80 mg ()

OXYCODONE HCl EXTENDED-RELEASE TABLETS are contraindicated in patients with:

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

No data

Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
Adrenal Insufficiency
Severe Hypotension
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
Risk of Obstruction in Patients who have Difficulty Swallowing or have Underlying GI Disorders that may Predispose them to Obstruction

The following serious adverse reactions are described elsewhere in the labeling:
Most common adverse reactions (incidence >5%) were constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating. ()
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Table 4 includes clinically significant drug interactions with OXYCODONE HCl EXTENDED-RELEASE TABLETS.

CNS Depressants
Serotonergic Drugs
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Monoamine Oxidase Inhibitors (MAOIs)

Pregnancy
Lactation

No data

Clinical Presentation
Acute overdose with OXYCODONE HCl EXTENDED-RELEASE TABLETS can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.
Treatment of Overdose
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to oxycodone overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose.
Because the duration of reversal is expected to be less than the duration of action of oxycodone in OXYCODONE HCl EXTENDED-RELEASE TABLETS, carefully monitor the patient until spontaneous respiration is reliably reestablished. OXYCODONE HCl EXTENDED-RELEASE TABLETS will continue to release oxycodone and add to the oxycodone load for 24 to 48 hours or longer following ingestion, necessitating prolonged monitoring. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the productu2019s 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.

OXYCODONE HCl EXTENDED-RELEASE TABLETS are an opioid agonist supplied in 10 mg, 20 mg, 40 mg, and 80 mg tablets for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:
C H NO u2022 HCltMW 351.83
The chemical name is 4, 5u03b1-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.
Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7).
The 10 mg, 20 mg, 40 mg, and 80 mg tablets contain the following inactive ingredients: butylated hydroxytoluene (BHT), hypromellose, polyethylene glycol 400, polyethylene oxide, magnesium stearate, titanium dioxide.
The 10 mg tablets also contain hydroxypropyl cellulose.
The 20 mg tablets also contain polysorbate 80 and red iron oxide.
The 40 mg tablets also contain polysorbate 80 and yellow iron oxide.
The 80 mg tablets also contain hydroxypropyl cellulose, yellow iron oxide and FD&C Blue #2/Indigo Carmine Aluminum Lake.

No data

Carcinogenesis
Long-term studies in animals to evaluate the carcinogenic potential of oxycodone have not been conducted.
Mutagenesis
Oxycodone was genotoxic in the mouse lymphoma assay. Oxycodone was negative when tested at appropriate concentrations in the chromosomal aberration assay, the bacterial reverse mutation assay (Ames test), and the bone marrow micronucleus assay in mice.
Impairment of Fertility
In a study of reproductive performance, rats were administered a once daily gavage dose of the vehicle or oxycodone hydrochloride (0.5, 2, and 8 mg/kg/day). Male rats were dosed for 28 days before cohabitation with females, during the cohabitation and until necropsy (2-3 weeks post-cohabitation). Females were dosed for 14 days before cohabitation with males, during cohabitation and up to Gestation Day 6. Oxycodone hydrochloride did not affect reproductive function in male or female rats at any dose tested (up to 8 mg/kg/day), up to 1.3 times a human dose of 60 mg/day.

Adult Clinical Study
A double-blind, placebo-controlled, fixed-dose, parallel group, two-week study was conducted in 133 patients with persistent, moderate to severe pain, who were judged as having inadequate pain control with their current therapy. In this study, OXYCODONE HCl EXTENDED-RELEASE TABLETS 20 mg, but not 10 mg, was statistically significant in pain reduction compared with placebo.
Pediatric Clinical Study
OXYCODONE HCl EXTENDED-RELEASE TABLETS has been evaluated in an open-label clinical trial of 155 opioid-tolerant pediatric patients with moderate to severe chronic pain. The mean duration of therapy was 20.7 days (range 1 to 43 days). The starting total daily doses ranged from 20 mg to 100 mg based on the patientu2019s prior opioid dose. The mean daily dose was 33.30 mg (range 20 to 140 mg/day). In an extension study, 23 of the 155 patients were treated beyond four weeks, including 13 for 28 weeks. Too few patients less than 11 years were enrolled in the clinical trial to provide meaningful safety data in this age group.

OXYCODONE HCl EXTENDED-RELEASE TABLETS 10 mg are film-coated, round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 ().
OXYCODONE HCl EXTENDED-RELEASE TABLETS 20 mg are film-coated, round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 ().
OXYCODONE HCl EXTENDED-RELEASE TABLETS 40 mg are film-coated, round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 ().
OXYCODONE HCl EXTENDED-RELEASE TABLETS 80 mg are film-coated, round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 ().
Store at 25u00b0C (77u00b0F); excursions permitted between 15u00b0-30u00b0C (59u00b0-86u00b0F) [see USP Controlled Room Temperature].
Store OXYCODONE HCl EXTENDED-RELEASE TABLETS securely and dispose of properly .
Dispense in tight, light-resistant container.

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 OXYCODONE HCl 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 OXYCODONE HCl EXTENDED-RELEASE TABLETS unsecured can pose a deadly risk to others in the home.
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused OXYCODONE HCl 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.
Inform patients that the use of OXYCODONE HCl EXTENDED-RELEASE TABLETS, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death Instruct patients not to share OXYCODONE HCl EXTENDED-RELEASE TABLETS with others and to take steps to protect OXYCODONE HCl EXTENDED-RELEASE TABLETS from theft or misuse.
Arrayn- Life-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting OXYCODONE HCl EXTENDED-RELEASE TABLETS or when the dosage is increased, and that it can occur even at recommended dosages Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
To guard against excessive exposure to OXYCODONE HCl EXTENDED-RELEASE TABLETS by young children, advise caregivers to strictly adhere to recommended OXYCODONE HCl EXTENDED-RELEASE TABLETS dosing.
Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death n
Interactions with Benzodiazepines or Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if OXYCODONE HCl EXTENDED-RELEASE TABLETS are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider n
Serotonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare provider if they are taking, or plan to take serotonergic medications n
MAOI Interaction
Inform patients to avoid taking OXYCODONE HCl EXTENDED-RELEASE TABLETS while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking OXYCODONE HCl EXTENDED-RELEASE TABLETS n
Adrenal Insufficiency
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms n
Important Administration Instructions
Instruct patients how to properly take OXYCODONE HCl EXTENDED-RELEASE TABLETS, including the following:
Important Discontinuation Instructions
In order to avoid developing withdrawal symptoms, instruct patients not to discontinue OXYCODONE HCl EXTENDED-RELEASE TABLETS without first discussing a tapering plan with the prescriber n
Hypotension
Inform patients that OXYCODONE HCl EXTENDED-RELEASE TABLETS may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position)n
Anaphylaxis
Inform patients that anaphylaxis has been reported with ingredients contained in OXYCODONE HCl EXTENDED-RELEASE TABLETS. Advise patients how to recognize such a reaction and when to seek medical attention n
Pregnancy
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that prolonged use of OXYCODONE HCl EXTENDED-RELEASE TABLETS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated n
Embryo-Fetal ToxicityInform female patients of reproductive potential that OXYCODONE HCl EXTENDED-RELEASE TABLETS can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy n
Lactation:
Advise patients that breastfeeding is not recommended during treatment with OXYCODONE HCl EXTENDED-RELEASE TABLETS n
Infertility
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible n
Driving or Operating Heavy Machinery
Inform patients that OXYCODONE HCl EXTENDED-RELEASE TABLETS may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication n
Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention n
u00a0
Healthcare professionals can telephone (1-866-832-8537) for information on this product.
Manufactured by:
Purdue Pharmaceuticals L.P.n
Distributed By:Teva Pharmaceuticals USA, Inc.n
U.S. Patent Numbers 7,129,248; 8,309,060; 8,808,741; 8,821,929; 8,894,987; 8,894,988; 9,073,933; 9,492,389; 9,492,391; 9,492,392u00a0; 9,492,393; 9,522,919; 9,675,610; 9,763,886; 9,763,933; 9,770,416; 9,775,808; 9,775,810; 9,775,811; 9,777,011; 10,130,591; 10,369,109 and 10,407,434.

OXYCODONE (OX-ee-KOH-dohn) HCl EXTENDED-RELEASE TABLETS , CII
OXYCODONE HCl EXTENDED-RELEASE TABLETS are:
Important information about OXYCODONE HCl EXTENDED-RELEASE TABLETS:
Do not take OXYCODONE HCl EXTENDED-RELEASE TABLETS if you have:
Before taking OXYCODONE HCl EXTENDED-RELEASE TABLETS, tell your healthcare provider if you have a history of:
Tell your healthcare provider if you are:
When taking n- OXYCODONE HCl EXTENDED-RELEASE TABLETS:
Dispose of expired, unwanted, or unused OXYCODONE HCl EXTENDED-RELEASE TABLETS by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
While taking OXYCODONE HCl EXTENDED-RELEASE TABLETS DO NOT:
The possible side effects of OXYCODONE HCl EXTENDED-RELEASE TABLETS are:
Get emergency medical help if you have:
These are not all the possible side effects of OXYCODONE HCl EXTENDED-RELEASE TABLETS. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. n
Distributed by: Teva Pharmaceuticals USA, Inc.,North Wales, PA 19454
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: 10/2019

NDC n- 5731
CII
Oxycodone Hydrochloride
Extended-release
Tablets
10 mg
Attention Dispenser
Medication Guide must be provided to
the patient upon dispensing.
Rx only
100 TABLETS
TEVA

NDC n- 5732
CII
Oxycodone Hydrochloride
Extended-release
Tablets
20 mg
Attention Dispenser
Medication Guide must be provided to
the patient upon dispensing.
Rx only
100 TABLETS
TEVA

NDC n- 5733
CII
Oxycodone Hydrochloride
Extended-release
Tablets
40 mg
Attention Dispenser
Medication Guide must be provided to
the patient upon dispensing.
Rx only
100 TABLETS
TEVA

NDC n- 5734
CII
Oxycodone Hydrochloride
Extended-release
Tablets
80 mg
Attention Dispenser
Medication Guide must be provided to
the patient upon dispensing.
for use in opioid-tolerant
patients only
Rx only
100 TABLETS
TEVA

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Oxycodone Hydrochloride (Oxycodone Hydrochloride)

Trade Name : Oxycodone Hydrochloride

TABLET, FILM COATED, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Oxycodone Hydrochloride (Oxycodone Hydrochloride)

Trade Name : Oxycodone Hydrochloride

TABLET, FILM COATED, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

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Browse from other international pharmaceuticals

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