Carbamazepine 100 mg/1
Carbamazepine · TABLET, EXTENDED RELEASE · Ascend Laboratories, LLC
Carbamazepine is a tablet, extended release containing carbamazepine at 100 mg/1, taken oral. Manufactured by Ascend Laboratories, LLC.
Key Facts
- Brand Name
- Carbamazepine
- Generic Name
- Carbamazepine
- NDC Code (Product)
67877-797- Manufacturer
- Ascend Laboratories, LLC
- Strength
- 100 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA217277
- Drug Class
- Mood Stabilizer [EPC]
- Marketing Start
- 11/01/2025
Recall History
Aidapak Services, LLC
Labeling: Label Mixup; carBAMazepine ER Tablet, 200 mg may be potentially mislabeled as ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: AD60272_1, EXP: 5/22/2014.
Taro Pharmaceuticals U.S.A., Inc.
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
The Harvard Drug Group
Failed Dissolution Specifications
Precision Dose Inc.
Subpotent Drug: low out of specification results.
Torrent Pharma Inc.
Failed Dissolution Specifications
Precision Dose Inc.
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Aidapak Services, LLC
Labeling:Label Mixup; carBAMazepine ER, Capsule, 200 mg may be potentially mislabeled as ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: AD46333_1, EXP: 5/15/2014.
Torrent Pharma Inc.
Failed Dissolution Specifications
Amerisource Health Services LLC
Failed Dissolution Specifications.
Aidapak Services, LLC
Labeling: Label Mixup: carBAMazepine ER, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: ISOSORBIDE DINITRATE ER, Tablet, 40 mg, NDC 57664060088, Pedigree: AD23082_4, EXP: 5/3/2014; SIROLIMUS, Tablet, 1 mg, NDC 00008104105, Pedigree: W003329, EXP: 6/18/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS , General). Trigeminal Neuralgia Carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
Dosage & Administration
DOSAGE AND ADMINISTRATION (SEE TABLE BELOW) Carbamazepine suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of patient passing an orange rubbery precipitate in the stool following coadministration of the two drugs (see PRECAUTIONS, Drug Interactions). Because the extent to which this occurs with other liquid medications is not known, Carbamazepine suspension should not be administered simultaneously with other liquid medications or diluents. Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests). Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Medication should be taken with meals. Since a given dose of Carbamazepine suspension will produce higher peak levels than the same dose given as the tablet, it is recommended to start with low doses (children 6 to 12 years: ½ teaspoon four times a day and to increase slowly t…
Contraindications
CONTRAINDICATIONS Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits. Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated.
Drug Interactions
Drug Interactions There has been a report of a patient who passed an orange rubbery precipitate in his stool the day after ingesting carbamazepine suspension immediately followed by Thorazine solution. Subsequent testing has shown that mixing carbamazepine suspension and chlorpromazine solution (both generic and brand name) as well as carbamazepine suspension and liquid Mellaril, resulted in the occurrence of this precipitate. Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medicinal agents or diluents (see DOSAGE AND ADMINISTRATION). Clinically meaningful drug interactions have occurred with concomitant medications and include (but are not limited to) the following: Agents That May Affect Carbamazepine Plasma Levels When carbamazepine is given with drugs that can increase or decrease carbamazepine levels, close monitoring of carbamazepine levels is indicated and dosage adjustment may be required. Agents That Increase Carbamazepine Levels CYP3A4 inhibitors inhibit carbamazepine metabolism and can thus increase plasma carbamazepine levels. Drugs that have been sho…
Adverse Reactions
ADVERSE REACTIONS If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards. The most severe adverse reactions have been observed in the hemopoietic system and skin (see BOXED WARNING), the liver, and the cardiovascular system. The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended. The following additional adverse reactions have been reported: Hemopoietic System : Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda. Skin : Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see BOXED WARNING), Acute Generalized Exanthematous Pustulosis (AGEP), pruritic and erythematous rashes, urticaria, …
Frequently Asked Questions
What is Carbamazepine used for?
Carbamazepine contains Carbamazepine. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Carbamazepine a controlled substance?
Carbamazepine is not classified as a controlled substance by the DEA.
What is the generic name for Carbamazepine?
The generic name for Carbamazepine is Carbamazepine. There are 3 other brand versions of Carbamazepine.
What is the NDC code for Carbamazepine 100 mg/1?
The NDC (National Drug Code) for Carbamazepine 100 mg/1 is 67877-797, listed by Ascend Laboratories, LLC.