Application Nr Approved Date Route Status External Links
ANDA070918 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & 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, Even At Recommended Doses [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

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE ZINC3812989

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