bupivacaine hydrochloride
bupivacaine hydrochloride is listed in the FDA National Drug Code directory with 17 NDC codes, marketed under brand names including bupivacaine hydrochloride, Bupivacaine Hydrochloride, Marcaine. Available dosage form: injection, solution.
Drug Details
- Generic Name
- bupivacaine hydrochloride
- Brand Names
- bupivacaine hydrochloride, Bupivacaine Hydrochloride, Marcaine, Sensorcaine MPF, BUPIVACAINE HYDROCHLORIDE
- Application Number
- ANDA216040
- Sponsor
- Meitheal Pharmaceuticals Inc
- NDC Codes
- 17
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- EPIDURAL, RETROBULBAR, INFILTRATION, INTRACAUDAL, PERINEURAL
- Active Ingredients
- BUPIVACAINE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. Bupivacaine hydrochloride injection contains bupivacaine, an amide local anesthetic. Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. ( 1 , 2.2 ) Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use. ( 1 , 2.2 , 4 , 5.1 , 5.4 , 5.5 , 5.7 , 5.9 ) Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration (2.2) , Contraindications (4) , Warnings and Precautions (5.1 , 5.4 , 5.5 , 5.7 , 5.9) ] .