NDC 47335-0860-83
TRAMADOL HYDROCHLORIDE 200 mg/1 TABLET, EXTENDED RELEASE
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NDC
47335-0860-83
Generic Name
TRAMADOL HYDROCHLORIDE
Brand Name
TRAMADOL HYDROCHLORIDE
Strength
200 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Package Size
—
Labeler
Sun Pharmaceutical Industries, Inc.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Tramadol hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use • Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosages or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid a…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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