oxymorphone hydrochloride
oxymorphone hydrochloride is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Oxymorphone Hydrochloride. Available dosage form: tablet.
Drug Details
- Generic Name
- oxymorphone hydrochloride
- Brand Names
- Oxymorphone Hydrochloride
- Application Number
- ANDA090964
- Sponsor
- Hikma Pharmaceuticals USA Inc.
- NDC Codes
- 2
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- OXYMORPHONE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Oxymorphone hydrochloride tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve oxymorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia Oxymorphone hydrochloride tablets are an opioid agonist indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve oxymorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia