morphine sulfate
morphine sulfate is listed in the FDA National Drug Code directory with 37 NDC codes, marketed under brand names including Morphine sulfate, INFUMORPH 200, Morphine Sulfate. Available dosage forms: tablet, film coated, extended release, injection, solution, capsule, extended release, injection, tablet.
Drug Details
- Generic Name
- morphine sulfate
- Brand Names
- Morphine sulfate, INFUMORPH 200, Morphine Sulfate, MS Contin, Duramorph, INFUMORPH 500
- Application Number
- ANDA078761
- Sponsor
- Sun Pharmaceutical Industries, Inc.
- NDC Codes
- 37
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE, INJECTION, SOLUTION, CAPSULE, EXTENDED RELEASE, INJECTION, TABLET, SOLUTION
- Routes
- ORAL, EPIDURAL, INTRATHECAL, INTRAVENOUS
- Active Ingredients
- MORPHINE SULFATE
Indications and Usage
1 INDICATIONS AND USAGE Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use : ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.1 ), reserve Morphine Sulfate Injection 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 Morphine Sulfate Injection should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Morphine Sulfate Injection is indicated for the management of 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, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )] , reserve Morphine Sulfate Injection 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 Morphine Sulfate Injection should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.