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NDC 16571-0682-01

CARBAMAZEPINE 400 mg/1 TABLET, EXTENDED RELEASE

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NDC
16571-0682-01
Generic Name
CARBAMAZEPINE
Brand Name
CARBAMAZEPINE
Strength
400 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Package Size
—
Labeler
Rising Pharma Holdings, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Epilepsy Carbamazepine Extended-Release Tablet 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: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. Generalized tonic-clonic seizures (grand ma…

Important Warnings

WARNINGS Serious Dermatologic Reactions Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with Carbamazepine treatment. The risk of these events is estimated to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations. However, the risk in some Asian countries is estimated…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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Other CARBAMAZEPINE NDC Codes

51672-4123-01100 mg/1TABLET, EXTENDED RELEASE
2-Day
13668-0271-01100 mg/1TABLET, CHEWABLE
2-Day
51672-4041-01100 mg/1TABLET, CHEWABLE
2-Day
51672-4124-01200 mg/1TABLET, EXTENDED RELEASE
2-Day
51672-4005-03200 mg/1TABLET
2-Day

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