nalbuphine hydrochloride
nalbuphine hydrochloride is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Nalbuphine Hydrochloride. Available dosage form: injection.
Drug Details
- Generic Name
- nalbuphine hydrochloride
- Brand Names
- Nalbuphine Hydrochloride
- Application Number
- ANDA216049
- Sponsor
- Henry Schein, Inc.
- NDC Codes
- 2
- Dosage Forms
- INJECTION
- Routes
- INTRAMUSCULAR, INTRAVENOUS, SUBCONJUNCTIVAL, SUBCUTANEOUS
- Active Ingredients
- NALBUPHINE HYDROCHLORIDE
Indications and Usage
INDICATIONS AND USAGE Nalbuphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine hydrochloride injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. Limitations of Use: Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS ], reserve nalbuphine hydrochloride injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. Nalbuphine hydrochloride 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.