Oxcarbazepine 600 mg/1
Oxcarbazepine · TABLET, FILM COATED · ANI Pharmaceuticals, Inc.
Oxcarbazepine is a tablet, film coated containing oxcarbazepine at 600 mg/1, taken oral. Manufactured by ANI Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Oxcarbazepine
- Generic Name
- Oxcarbazepine
- NDC Code (Product)
62559-222- Manufacturer
- ANI Pharmaceuticals, Inc.
- Strength
- 600 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA078005
- Drug Class
- Anti-epileptic Agent [EPC]
- Marketing Start
- 07/15/2025
Recall History
West-Ward Columbus Inc
Failed Impurities/Degradation Specificattion
Caraco Pharmaceutical Laboratories Ltd.
Failed Tablet Specifications: Broken Tablets Present.
Aidapak Services, LLC
Labeling:Label Mixup; OXcarbazepine Tablet, 150 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC 50111043301, Pedigree: AD54562_1, EXP: 5/20/2014.
Aidapak Services, LLC
Labeling:Label Mixup; OXcarbazepine Tablet, 600 mg may be potentially mislabeled as LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD30028_25, EXP: 5/7/2014.
SUN PHARMACEUTICAL INDUSTRIES INC
Presence of foreign substance
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Boehringer Ingelheim Roxane Inc
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Boehringer Ingelheim Roxane Inc
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
American Health Packaging
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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 Oxcarbazepine oral suspension is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine oral suspension is indicated for: • Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures • Pediatrics: -Monotherapy in the treatment of partial-onset seizures in children 4 to 16 years -Adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults : Initiate with a dose of 600 mg/day, given twice a day • Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1,200 mg/day ( 2.1 ) • Conversion to Monotherapy: Withdrawal concomitant over 3 to 6 weeks; reach maximum dose of oxcarbazepine oral suspension in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2,400 mg/day ( 2.2 ) • Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1,200 mg/day ( 2.3 ) • Initiate at one-half the usual starting dose and increase slowly in patients with a creatinine clearance < 30 mL/min ( 2.7 ) Pediatrics : Initiation with 8 to 10 mg/kg/day, given twice a day. For patients aged 2 to < 4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight. • Adjunctive Patients (Aged 2 to 16 Years): For patients aged 4 to 16 years, target maintenance dose should be achieved over 2 weeks ( 2.4 ). For patients aged 2 to < 4 years, maximum maintenance dose should be achieved over 2 to 4 weeks and should not exceed 60mg/k…
Contraindications
4 CONTRAINDICATIONS Oxcarbazepine oral suspension is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [see Warnings and Precautions (5.2, 5.3 )]. Known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate ( 4, 5.2 )
Drug Interactions
7 DRUG INTERACTIONS • Phenytoin: Increased phenytoin levels. Reduced dose of phenytoin may be required ( 7.1) • Carbamazepine, Phenytoin, and Phenobarbital: Decreased plasma levels of MHD (the active metabolite). Dose adjustments may be necessary ( 7.1 ) • Oral Contraceptive: Oxcarbazepine may decrease the effectiveness of hormonal contraceptives ( 7.3 ) 7.1 Effect of Oxcarbazepine on Other Drugs Phenytoin levels have been shown to increase with concomitant use of oxcarbazepine at doses greater than 1,200 mg/day [see Clinical Pharmacology (12.3) ]. Therefore, it is recommended that the plasma levels of phenytoin be monitored during the period of oxcarbazepine titration and dosage modification. A decrease in the dose of phenytoin may be required. 7.2 Effect of Other Drugs on Oxcarbazepine Strong inducers of cytochrome P450 enzymes and/or inducers of UGT (e.g., rifampin, carbamazepine, phenytoin and phenobarbital) have been shown to decrease the plasma/serum levels of MHD, the active metabolite of oxcarbazepine (25% to 49%) [see Clinical Pharmacology (12.3) ]. If oxcarbazepine and strong CYP3A4 inducers, or UGT inducers are administered concurrently, it is recommended that the plasma…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Hyponatremia [see Warnings and Precautions (5.1) ] • Anaphylactic Reactions and Angioedema [see Warnings and Precautions (5.2) ] • Cross Hypersensitivity Reaction to Carbamazepine [see Warnings and Precautions (5.3) ] • Serious Dermatological Reactions [see Warnings and Precautions (5.4) ] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ] • Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.7) ] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see Warnings and Precautions (5.8) ] • Hematologic Events [see Warnings and Precautions (5.9) ] The most common (≥ 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and abnormal gait ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Be…
Frequently Asked Questions
What is Oxcarbazepine used for?
Oxcarbazepine contains Oxcarbazepine. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Oxcarbazepine a controlled substance?
Oxcarbazepine is not classified as a controlled substance by the DEA.
What is the generic name for Oxcarbazepine?
The generic name for Oxcarbazepine is Oxcarbazepine. There are 5 other brand versions of Oxcarbazepine.
What is the NDC code for Oxcarbazepine 600 mg/1?
The NDC (National Drug Code) for Oxcarbazepine 600 mg/1 is 62559-222, listed by ANI Pharmaceuticals, Inc..