Application Nr Approved Date Route Status External Links
ANDA070597 None Perineural None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Bupivacaine Hydrochloride Is Indicated For The Production Of Local Or Regional Anesthesia Or Analgesia For Surgery, Dental And Oral Surgery Procedures, Diagnostic And Therapeutic Procedures, And For Obstetrical Procedures. Only The 0.25% And 0.5% Concentrations Are Indicated For Obstetrical Anesthesia. (See Warnings .) Experience With Nonobstetrical Surgical Procedures In Pregnant Patients Is Not Sufficient To Recommend Use Of 0.75% Concentration Of Bupivacaine Hydrochloride In These Patients. Bupivacaine Hydrochloride Is Not Recommended For Intravenous Regional Anesthesia (Bier Block). (See Warnings .) The Routes Of Administration And Indicated Bupivacaine Hydrochloride Concentrations Are: (See Dosage And Administration For Additional Information.) Standard Textbooks Should Be Consulted To Determine The Accepted Procedures And Techniques For The Administration Of Bupivacaine Hydrochloride. Image3.jpg

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE ZINC1530812

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