Oxycodone Hydrochloride 5 mg/5mL
Oxycodone Hydrochloride · SOLUTION · Bryant Ranch Prepack
Oxycodone Hydrochloride is a solution containing oxycodone hydrochloride at 5 mg/5mL, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Oxycodone Hydrochloride
- Generic Name
- Oxycodone Hydrochloride
- NDC Code (Product)
63629-2104- Manufacturer
- Bryant Ranch Prepack
- Strength
- 5 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA204979
- Marketing Start
- 10/13/2015
Recall History
Amerisource Health Services LLC
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Akorn, Inc.
Labeling: Missing Label
Ascent Pharmaceuticals, Inc.
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Boehringer Ingelheim Roxane Inc
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Lupin Pharmaceuticals Inc.
Out-of-specification impurity test result observed at 18-month long term stability time point.
VistaPharm, Inc.
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
American Health Packaging
Impurity failure at 0-time of the repackaged lot.
VistaPharm, Inc.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Genus Lifesciences Inc.
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Rhodes Pharmaceuticals, L.P.
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)] , reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxycodone hydrochloride is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1) Limitations of Use : Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including oxycodone hydrochloride for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide suffic…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Oxycodone hydrochloride tablets 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 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 case and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. (2.1, 5.1) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases w…
Contraindications
4 CONTRAINDICATIONS Oxycodone hydrochloride is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2)]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see Warnings and Precautions (5.8)]. Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12)] . Known hypersensitivity (e.g., anaphylaxis) to oxycodone [see Adverse Reactions (6.2)]. Significant respiratory depression (4) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment (4) Known or suspected gastrointestinal obstruction, including paralytic ileus (4) Hypersensitivity to oxycodone (4)
Drug Interactions
7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with oxycodone hydrochloride. Table 1: Clinically Significant Drug Interactions with Oxycodone Hydrochloride Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of oxycodone hydrochloride 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 and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of oxycodone hydrochloride is achieved [see Warnings and Precautions (5.3)] . 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 until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor…
Adverse Reactions
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 (5.1)] 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-Induce Hyperalgesia and Allodynia [see Warnings and Precautions (5.7)] Adrenal Insufficiency [see Warnings and Precautions (5.9)] Severe Hypotension [see Warnings and Precautions (5.10)] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12)] Seizures [see Warnings and Precautions (5.13)] Withdrawal [see Warnings and Precautions (5.14)] Most common adverse reactions (≥3%) were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Camber Pharmaceuticals Inc., at 1-866-495-8330 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse…
Frequently Asked Questions
What is Oxycodone Hydrochloride used for?
Oxycodone Hydrochloride contains Oxycodone Hydrochloride. It is a solution taken oral. Consult your doctor for specific uses.
Is Oxycodone Hydrochloride a controlled substance?
Yes, Oxycodone Hydrochloride is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Oxycodone Hydrochloride?
The generic name for Oxycodone Hydrochloride is Oxycodone Hydrochloride. There are 4 other brand versions of Oxycodone Hydrochloride.
What is the NDC code for Oxycodone Hydrochloride 5 mg/5mL?
The NDC (National Drug Code) for Oxycodone Hydrochloride 5 mg/5mL is 63629-2104, listed by Bryant Ranch Prepack.
Other Oxycodone Hydrochloride Dosages
- Oxycodone Hydrochloride15 mg/176420-364
- Oxycodone Hydrochloride15 mg/142806-007
- Oxycodone Hydrochloride5 mg/142858-001
- Oxycodone Hydrochloride10 mg/143386-433
- Oxycodone Hydrochloride10 mg/164380-260
- Oxycodone Hydrochloride20 mg/164380-262
- Oxycodone Hydrochloride30 mg/164380-263
- Oxycodone Hydrochloride5 mg/168071-2899
Other Oxycodone Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)