tramadol hydrochloride
tramadol hydrochloride is listed in the FDA National Drug Code directory with 17 NDC codes, marketed under brand names including tramadol hydrochloride, Tramadol Hydrochloride Extended-Release, Tramadol Hydrochloride. Available dosage forms: tablet, capsule, solution, capsule, extended release.
Drug Details
- Generic Name
- tramadol hydrochloride
- Brand Names
- tramadol hydrochloride, Tramadol Hydrochloride Extended-Release, Tramadol Hydrochloride, ConZip
- Application Number
- ANDA202075
- Sponsor
- Strides Pharma Science Limited
- NDC Codes
- 17
- Dosage Forms
- TABLET, CAPSULE, SOLUTION, CAPSULE, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- TRAMADOL HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Tramadol hydrochloride extended-release tablet is 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 analgesics, including tramadol hydrochloride extended-release 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. Tramadol hydrochloride extended-release tablet is not indicated as an as-needed (prn) analgesic. Tramadol hydrochloride extended-release tablets are an opioid agonist 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. ( 1 ) 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 , reserve opioids analgesics, including tramadol hydrochloride extended-release 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. ( 1 ) Tramadol hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic. ( 1 )